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DRAFT FOR COMMENTS  4 
as of 23 May  2017  5 
[Date stamp here]  6 
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ADMINISTRATIVE ORDER  8 
No. ______ _____ ______ ____ _ 9 
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SUBJECT:  REVISED  REGULATORY GUIDELINES CONCERNING FOOD 11 
ADDITIVES , AND  PROCESSING AID S 12 
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I.  RATIONALE  15 
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The 1987 Philippine Constitution declares under Article II, Section 15 to “protect and 17 
promote the right to health of the people and instill health consciousness among them. ” 18 
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Republic Act 9711 or the Food and Drug Act of 2009, Section 3 declares that it is “a policy 20 
of the State  to adopt, support, establish, institutionalize, improve and maintain structures, 21 
processes, mechanisms and initiatives that are aimed, directed and designed to: (a) protect 22 
and promote the right to health of th e Filipino people; and (b) help establish and maintain 23 
an effective health products regulatory system and undertake appropriate health manpower 24 
development and research, responsive to the country ’s health needs and problems. Pursuant 25 
to this policy, the St ate must enhance its regulatory capacity and strengthen its capacity 26 
with regards to inspection, licensing and monitoring of establishments and the registration 27 
and monitoring of health products. ”  28 
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The Implementing Rules and Regulations of RA 9711 further states that  Food and Drug 30 
Administration (FDA)  is tasked to “establish standards and quality measures for food and 31 
adopt measures to ensure quality and safe supply of food in the country.  32 
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Furthermo re, Republic Act 10611 or the Food Safety Act of 2013, Section 9 states that the 34 
Department of Health – Food and Drug Administration ( DOH -FDA ) “shall set the 35 
mandatory food safety standards ” and that “Standards shall be established on the basis of 36 
science, risk analysis, scientific advice from expert body/bodies, standards of other 37 
countries, existing Philippine National Standards (PNS) and the standards of the Codex 38 
Alimentarius Commission (Codex), where these exist and are applicable. ”  39 
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Administrative Order (AO) No. 88 -A s. 1984 and Bureau Circular  (BC)  No. 2006 -0016 41 
need updating to meet the current and emerging trends in food manufacturing. In view of 42 
the above and consistent with the requirements of the World Trade Organ ization on 43 
Technical Barriers t o Trade in overcoming technical obstacles in world markets, these 44 
guidelines aim  to update and put toget her the list of permitted food additive s and prescribe 45 
standards  for their use and application in food distributed  in the Philippines whether locally 46 
manufactured or imported.  47 
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II. OBJECTIVES  65 
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These guidelines are meant to achieve the following objectives:  67 
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1. To establish guidelines  prescribing:  69 
a. The condition under whic h a food additive may be safely  used; and  70 
b. The maximum quantity food of additive which may be used or permitted to 71 
remain in or on such food;  72 
2. To meet the demand for specific guidance on the use of food additives  and ensu re 73 
food safety , with the increasing awareness for safe food ;  74 
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3. To harmonize local food regulation with international food control laws, rules and 76 
regulations and to ensure market access opp ortunities ; and  77 
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4. To update the list of permitted food additives and  prescribe guidelines for their use 79 
and application in food distributed in the Philippines.  80 
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5. To provide guidelines in the approval of proposed new Food Additives.  82 
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III. SCOPE  84 
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This Order shall apply to all manufacturers, importers, exporters, traders, wholesalers 86 
and distributors of food products.  87 
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IV. DEFINITION OF TERMS  89 
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As used in this document, the terms below shall be defined as follows:  91 
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1. Food Additive  means any substance not normally consumed as a food by itself and 93 
not normally used as a typical ingredient of the food, whether or not it has nutritive 94 
value, the intentional addition of which to food for a technological (including 95 
organoleptic) purpose in the manufacture, processing, preparation, treatment, 96 
packing, packaging, transport or holding o f such food results, or may be reasonably 97 
expected to result (directly or indirectly), in it or its by -products becoming a 98 
component of or otherwise affecting the characteristics of such foods. The term 99 
does not include contaminants or substances added to food for maintaining or 100 
improving nutritional qualities.1 101 
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2. Flavoring Substances  refers to flavor preparations composed of substances derived 103 
from plant/ animal products and/or chemically synthesized substances whose 104 
significant function in food is flavo ring rather than nutritional.2 105 
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1 Codex Alimentarius Procedural Manual.  107 
2 Administrative Order 88 -B s. 1984 (Rules and Regulations Governing the Labelling of Prepackaged Food Products Distributed in the 108 
Philippines)  109 
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3. Processing Aid  means any substance or material, not including apparatus or 128 
utensils, and not consumed as a food ingredient by itself, intentionally used in the 129 
processing of raw materials, foods or its ingredients to fulfil a certain technological 130 
purpose during treatme nt or processing and which may result in the non -intentional 131 
but unavoidable presence of residues or derivatives in the final product.1 132 
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4. Enzymes are proteins capable of catalyzing biochemical processes, acting on 134 
specific substrates and in relative low amo unts. 135 
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5. Artificial/synthetic Food Colors  are derived from petroleum distillates or coal tars 137 
and are essentially synthetic chemicals created in laboratories.  138 
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6. Natural Food Colors  are derived from plant, animal or mineral sources which have 140 
been processed in some way.  141 
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7. Acceptable Daily Intake  or ADI refers to an estimate by the JECFA of the amount 143 
of a food additive, expressed on a body weight basis, that can be ingested daily over 144 
a lifetime without appreciable health risk.3 145 
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8. Maximum Use Level of an additive is the highest concentration of the additive 147 
determined to be functionally effective in a food or food category and agreed to be 148 
safe by the Codex Alimentarius Commission. It is ge nerally expressed as mg 149 
additive/kg of food. The maximum use level will not usually correspond to the 150 
optimum, recommended, or typical level of use. Under GMP, the optimum, 151 
recommended, or typical use level will differ for each application of an additive a nd 152 
is dependent on the intended technical effect and the specific food in which the 153 
additive would be used, taking into account the type of raw material, food 154 
processing and post -manufacture storage, transport and handling by distributors, 155 
retailers, and c onsumers.  156 
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9. GMP  refers to Good Manufacturing Practice  158 
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10. FAO  refers to Food and Agriculture Organization  160 
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11. FCC  refers to Food Chemicals Codex  162 
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12. GSFA  refers to General Standard for Food Additives  164 
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13. CCFA  refers to Codex Committee on Food Additives  166 
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14. IOFI  refers to International Organization for the Flavor Industry.  168 
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15. JECFA  refers to Joint FAO/WHO Experts Committee on Food Additives.  170 
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16. WHO  refers to World Health Organization.  172 
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17. US FEMA  refers to United States Flavor Extracts Manufacturers Association.  174 
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1 Codex Alimentarius Procedural Manual.  177 
2 Administrative Order 88 -B s. 1984 (Rules and Regulations Governing the Labelling of Prepackaged Food Products Distributed in the 178 
Philippines)  179 
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V. GENERAL GUIDELINES  200 
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A. General Principles for the Use of Food Additives  202 
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The use of food additives in conformance with this Order requires adherence to all 204 
the principles set forth in the following provision:  205 
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1. Food Additive Safety  – The safety of food additives must be guided by the 207 
following principles : 208 
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a. Only those food additives which present no appreciable risk to health of the 210 
consumer at the proposed level of use for specified food category as assessed by 211 
JECFA , present no appreciable health risk to consumers at the use levels 212 
proposed . 213 
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b. The inclusion of a food additive shall have taken into account any ADI, or 215 
equivalent safety assessment established for the additive by JECFA and its 216 
probable daily intake from all food sources. Where the food additive is to be 217 
used in food eaten by special groups of co nsumers (e.g. diabetics, those on 218 
special medical diets, sick individuals on formulated liquid diets) account shall 219 
be taken of the probable daily intake of the food additive by those consumers.  220 
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c. The quantity of an additive added to food is at or below the  maximum use 222 
leveland is the lowest level necessary to achieve the intended technical effect. 223 
The maximum use level may be based on the application of procedures as 224 
recommended by JECFA, the intake assessment of Codex members or upon 225 
request by the CCFA to  JECFA for an independent evaluation of national intake 226 
assessment.  227 
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2. Justification for the Use of Additives  229 
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The use of food additives is justified only when such use has an advantage, does 231 
not present an appreciable health risk to consumers, does not mislead the 232 
consumer, and serves one or more of the technological functions (see Annex A 233 
for the Food Additives F unctional Classes , Definitions and Technological 234 
Purposes ) and the needs set out below from (a) to (d), and only where these 235 
objectives cannot be achieved by other means that are economically and 236 
technologically practicable:  237 
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a. To preserve the nutritional qu ality of the food; an intentional reduction in 239 
the nutritional quality of a food would be justified in the circumstances dealt 240 
with in (b) and also in other circumstances where the food does not 241 
constitute a significant item in a normal diet;  242 
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3 Principles for the Safety Assessment of Food Additives and Contaminants in Food, World Health Organization, (WHO Environmenta l 244 
Health   Criteria, No. 70), p. 111 (1987). For the purposes of this Standard, the phrase “without appreciable health risk ” means that 245 
there is a reasonable certainty of no harm to consumers if an additive is used at levels that do not exceed those in this Sta ndard. The 246 
provisions of this Standard do not sanction the use of an additive in a manner that would adversely affect consume r health.  247 
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b. To provide necessary ingredients or const ituents for foods manufactured for 266 
groups of consumers having special  dietary needs;  267 
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c. To enhance the keeping quality or stability of a food or to improve its 269 
sensory properties, provided that this does no t change the nature, substance 270 
or quality of the food so as to dece ive the consumer; and  271 
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d. To provide aids in the manufacture, processing, preparation, treatment, 273 
packing, transport or storage of food, provided that the additive is not used 274 
to disguise the effects of the use of faulty raw materials or of undesirable 275 
(including unhygienic) pra ctices or techniques during the  course of any of 276 
these activities.  277 
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3. The Permitted Levels of Use of Food Additives  279 
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The primary objective of establishing permitted levels  of use of food additives 281 
in various food groups is to ensure that the intake of additives does not exceed 282 
the acceptable daily intake (ADI).  283 
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The maximum use level of food additives are  based in part on FDA commodity 285 
standards, Codex and upon request of interested parties after subjecting their 286 
proposed maximum use level  to internationally accepted scientific methods, 287 
ensuring that the same shall not exceed prescribed ADI.  288 
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4. Good Manufact uring Practice (GMP)  290 
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All food additives covered by these guidelines  shall be used under conditions of 292 
good manufacturing practice, which include the following:  293 
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a. The quantity of at the additive added to food shall be limited to the lowest 295 
possible level ne cessary to accomplish its desired effect; unless specifically 296 
limited by these guidelines  for or to a specific application;  297 
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b. The quantity of the additive that becomes a component of food as a result of 299 
its use in the manufacturing, processing or packaging of a food and which is 300 
not intended to accomplish any physical, or other technical effect in the food 301 
itself, is reduced to the extent reasonably possible; and,  302 
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c. The food additive is of food grade quality and is prepared and handled in the 304 
same way as a food ingredient.  305 
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5. Specifications for the Identity and Purity of Food Additives  307 
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Food additives used in accordance with these guidelines should be of appropriate 309 
food grade quality and should at all times conform with the applicable 310 
Specifications of Identity and Purity recommended by the Codex Alimentarius 311 
Commission or, in the absence of such specifications, with appropriate 312 
specifications deve loped by responsible national  or international bodies . In 313 
terms of safety, food grade quality is achieved by conformance of additives to 314 
their specifications as a whole (not merely with individual criteria) and through 315 
their production, storage, transport, and handling in accordance with GMP.  316 
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B. Carry -Over of Food Additives into Foods  326 
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1. Conditions Applying to Carry -Over of Food Additives from Ingredients and 328 
Raw Materials into Foods  329 
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Other than by direct addition, an additive maybe present in food as a result of 331 
carry -over from a raw material or ingred ient us ed to produce the food, provided 332 
that: 333 
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a. The additive is acceptable for use in  the raw materials or other ingredients 335 
(including food additives) according to these guidelines ; 336 
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b. The amount of the additive in the raw materials or other ingredients 338 
(including food additives) does not exceed the maximum use  level specified 339 
in these guidelines ; 340 
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c. The food into which the additive is carried over does not contain the 342 
additive in greater quantity than would be introduced by the use of raw 343 
materials, or ingredients under proper technological conditions or 344 
manufacturing practice, consistent with these g uidelines . 345 
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2. Special Conditions Applying to the Use of Food Additives not Directl y 347 
Authorized in Food Ingredients and Raw Materials  348 
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An additive may be used in or added to a raw material or other ingredient if the 350 
raw material or ingredient is used exclusive ly in the preparation of a food that is 351 
in conformity with these guidelines , provided that any maximum level applying 352 
to the food is not exceeded.  353 
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3. Foods for Which the Carry -Over of Food Additives is Unacceptable  355 
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Carry -over of a food additive from a raw material or ingredient is unacceptable 357 
for foods belonging to the following food categories;  unless a food additive 358 
provision in the specified category is listed in these guidelines : 359 
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a. 13.1 – Infant formula, follow -up formula, and formula for special medical 361 
purposes for infants  362 
b. 13.2 – Complementary foods for infants and young children.  363 
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C. Food Category System  365 
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The food category system is  a tool for assigning food additives uses outlined in 367 
these guidelines  and applies to all food stuffs . The food category system applies to 368 
all foodstuffs.  369 
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The food category descriptors are not to be treated as legal  product designations or  371 
intended , in any way,  for labelling purposes.  372 
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The food category system is based on the following principles:  374 
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1. The food category system is hierarchical, meaning that when an additive is 376 
recognized for use in a general category, it is recognized for use in all its sub - 377 
categories, unless otherwise stated . 378 
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Similarly, when an additive is recognized for use in a sub -category, its use is 380 
recognized in any further sub -categories or individual foodstuffs mentioned in a 381 
sub-category.  382 
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2. The food category system is based on product descriptors of foodstuffs as 388 
marketed, unless otherwise stated.  389 
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3. The food category systems take  into consideration the carry -over principle. By 391 
doing so, the food category system does not need to specifically mention 392 
compound foodstuffs (e.g. prepared meals, such as pizza, because they may 393 
contain, pro rata , all the addi tives endorsed for use in their components), unless 394 
the compound foodstuff needs an additive that is not endorsed for use in any of 395 
its components.  396 
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4. The food category system is used to simplify the reporting of food additive uses 398 
for assembling and constru cting these guidelines . 399 
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D. Provision for Mislabe led or Adulterated Food  401 
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Any food additive used not in accordance with the requirements of these guidelines  403 
shall be deemed to be an act which results in the food being misbranded or 404 
adulterated, as the case may be.  405 
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For violations under these guidelines , the sanctions provided under RA 9711 and its 407 
Implementing Rules and Regulations, and other allied laws and regulations may be 408 
imposed as far as applicable and after due notice and summary hearing.  409 
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E. Adoption of the Latest Codex General Standard for Food Additives  (GSFA)  411 
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The latest Codex General Standard for Food Additives  (GSFA), and its future 413 
revisions/ amendments/ updates,  shall be adopted automatically.  414 
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F. Request / Proposal  for New and/or Revision of Food Additive Provisions in the 416 
GSFA  417 
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Request or proposals for new and/or revision of Food Additives provisions in the 419 
GSFA shall follow the  Codex  “Procedure for Consideration for the Entry and 420 
Review of Food Additives Provisions in the GSFA ” and shall accomplish the form 421 
in Annex B of this Order.  422 
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VII.FLAVORING SUBSTANCES  424 
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If food additives are to be used as flavoring substances,  they shall  abide by the Codex 426 
Guidelines for the Use of Flavorings (CAC/GL 66 -2008) or as listed as safe in US 427 
FEMA and/or IOFI.  428 
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VIII. PROCESSING AIDS  430 
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The use of processing aids  shall be guided by at least any one  of the following latest 432 
revision: Food Chemicals Codex, USFDA CFR Title 21, the latest issuance of Codex 433 
Standard on Inventory of Processing Aids (CXA003e or CAC/MISC 3) and the latest 434 
issuance of Guidelines on Substances used as Processing Aids (CXG 075e / CAC/GL 435 
75-2010). For enzymes not listed in the Codex Inventory of Processing Aids, there 436 
should be certification from competent authority of country of origin.  437 
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X. TRANSITORY  PROVISION  452 
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Manufacturers, importers, exporters, traders, wholesalers and distributors  of processed 454 
food products distributed in the Philippines  are given a maximum of five (5 ) years 455 
transition  period for products with valid Certificate of Product Registration (CPR) 456 
starting from the effectivity date of this order to phase out e xisting stock s and labels, 457 
also to reformulate the product(s) to meet the standard specification for the food 458 
additive.  459 
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XI. FINAL PROVISIONS  462 
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A. Separability Clause  464 
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If any provision/s in this Order, or application of such provision to any 466 
circumstances, is held invalid, the remainder of its provisions shall not be affected  467 
thereby.  468 
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B. Repealing Clause  471 
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This Order repeals AO 88 -A. s. 1984, BC 2006 -0016, and other administrative 473 
order, rules and regulations, and administrative issuances or parts thereof that is/are 474 
inconsistent with its provisions.  475 
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C. Effectivity Clause  477 
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This Or der shall take effect 15 days after its publication in an official gazette or in a 479 
newspaper of general circulation and filing in the University of the Philippines Law 480 
Center.  481 
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      485 
   PAULYN JEAN B. RO SELL -UBIAL , MD, MPH, CESO II  486 
      Secretary of Health  487 
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4 All Codex adopted new levels of specific food additives, additional food categories under each food additives and/ or other n ew food 500 
additives included shall be adopted by FDA.  501 
  502 Keywords  Food Additives, Processing Aids  
Related issuances, laws, directives  Administrative Order (AO) 88 -A s. 1984  
Bureau Circular (BC) 2006 -0016  
Administrative Order (AO) 103 -A s. 1984  
Administrative Order (AO) 112 s. 1985  
Administrative Order (AO) 122 s. 1970  
 
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LIST OF ANNEXES  506 
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ANNEX A – Food Additives Functional Classes , Definitions and Technological Purposes  509 
ANNEX B  – Form for the Submission of Proposals for New and/or Revision of Adopted 510 
Food Additive Provisions in the GSFA  511 
ANNEX C –List of Repealed DOH/ FDA Issuances  512 
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ANNEX A  521 
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FOOD ADDITIVES FUNCTIONAL CLASSES,  523 
DEFINITIONS AND TECHNOLOGICAL PURPOSES  524 
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TABLE 1:  FOOD ADDITIVES FUNCTIONAL CLASSES, DEFINITIONS 527 
AND   TECHNOLOGICAL PURPOSES  528 
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Functional Classes  Definition  Technological Purpose  
1. Acidity regulator  A food additive, which controls the 
acidity or alkalinity of a food.  Acidity regulator, acid, 
acidifier, alkali, base, 
buffer, buffering agent, p H 
adjusting agent  
2. Anticaking agent  A food additive, which reduces the 
tendency of components of food to 
adhere to one another.  Anticaking agent, anti -stick 
agent, drying agent, dusting 
agent  
3. Antifoaming agent  A food additive, which prevents or 
reduces foaming.  Antifoaming agent, 
defoaming agent  
4. Antioxidant  A food additive, which prolongs the 
shelf -life of foods by protecting against 
deterioration caused by oxidation.  Antioxidant, antioxidant 
synergist, anti -browning 
agent  
5. Bleaching agent  A food additive  (non-flour use) used to 
decolo rize food. Bleaching agents do 
not include pigments.  Bleaching agent  
6. Bulking agent  A food additive, which contributes to 
the bulk of a food without contributing 
significantly to its available energy 
value.  Bulking agent, filler  
7. Carbonating agent  A food additive used to provide 
carbonation in a food.  Carbonating agent  
8. Carrier  A food additive used to dissolve, dilute, 
disperse or otherwise physically modify 
a food additive or nutrient without 
altering its function (and without 
exerting any technological effect itself) 
in order to facilitate its handling, 
application or use of the food additive 
or nutrient.  Carrier, carrier solvent, 
nutrient carrier, diluent for 
other food additives, 
encapsulating agent  
9. Colo r  A food additi ve, which adds or restores 
color in a food.  Colo r, decorative pigment, 
surface colo rant  
10. Colo r retention agent  A food additive, which stabilizes, 
retains or intensifies the colo r of a food.  Color retention agent, colo r 
fixative, color stabilizer, 
color adjunct  
11. Emulsifier  A food additive, which forms or 
maintains a uniform emulsion of two or 
more phases in a food.  Emulsifier, plasticizer, 
dispersing agent, surface 
active agent, crystallization 
inhibitor, density  
adjustment agent (flavo ring 
oils in beverages), 
suspension agent, clouding 
agent  
12. Emulsifying salt  A food additive, which, in the 
manufacture of processed food, 
rearranges proteins in order to prevent 
fat separation.  Emulsifying salt, melding 
salt  
13. Firming agent  A food additive, which makes or keeps 
tissues of fruit or vegetables firm and 
crisp, or interacts with gelling agents to 
produce or strengthen a gel.  Firming agent  
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Functional Classes  Definition  Technological Purpose  
14. Flavo r enhancer  A food additive, which enhance s the 
existing taste and/or odo r of a food.  Flavor enhancer, flavo r 
synergist  
15. Flour treatment agent  A food additive, which is added to flour 
or dough to imp rove its baking quality 
or colo r.  Flour treatment agent, flour 
bleaching agent, flour 
improver, dough 
conditioner, dough 
strengthening agent  
16. Foaming agent  A food additive, which makes it 
possible to form or maintain a uniform 
dispersion of a gaseous phase in a liquid 
or solid food.  Foaming agent, whipping 
agent, aerating agent  
17. Gelling agent  A food additive, which gives a food 
texture through formation of a gel.  Gelling agent  
18. Glazing agent  A food additive, which when applied to 
the external surface of a food, imparts a 
shiny appearance or provides a 
protective coating.  Glazing agent, sealing 
agent, coating agent, 
surface -finishing agent, 
polishing agent, film -
forming agent  
19. Humectant  A food additive, which prevents food 
from drying out by counteracting the 
effect of a dry atmosphere.  Humectant, moisture -
retention agent , wetting 
agent  
20. Packaging gas  A food additive gas, which is 
introduced into a container before, 
during or after  filling with food   with 
the intention to protect the food, for 
example, from oxidation or spoilage.  Packaging gas  
21. Preservative  A food additive, which prolongs the 
shelf -life of a food by protecting against 
deterioration caused by micro -
organisms.  Preservative, antimicrobial 
preservative, antimycotic 
agent, bacteriophage 
control agent, fungistatic 
agent, anti -mold and anti -
rope agent, antimicrobial 
synergist  
22. Propellant  A food additive gas, which expels a 
food from a container.  Propellant  
23. Raising agent  A food additive or a combination of 
food additives, which liberate(s) gas 
and thereby increase(s) the volume of a 
dough or batter.  Raising agent  
24. Sequestrant  A food additive, which controls the 
availability of a cation.  Sequestrant  
25. Stabilizer  A food additive, which makes it 
possible to maintain a uniform 
dispersion of two or more components.  Stabilizer, foam stabilizer, 
colloidal stabilizer, 
emulsion stabilizer  
26. Sweetener  A food additive (other than a mono - or 
disaccharide sugar), which imparts a 
sweet taste to a food.  Sweetener, intense 
sweetener, bulk sweetener  
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ANNEX B 543 
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FORM FOR THE SUBMISSION OF PRO POSALS FOR NEW AND/OR REVISION 546 
OF ADOPTED FOOD ADDITIVE PROVISIONS IN THE GSFA  547 
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In completing this form, only brief information is required. However, responsive 549 
information is required for each field. The form may be retyped if more space is needed 550 
under any one heading provided that the general format is maintained. A separate table 551 
should be completed  for each food additive.  552 
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THE PROPOSAL IS SUBMITTED BY:   
IDENTITY OF THE FOOD ADDITIVE:   
Name of the Additive:  
 
As listed in Class Names and the International 
Numbering System (INS) – CAC/GL 36 -1989   
INS NUMBER   
Functional Class  
 
As listed Class Names and the International 
Numbering System (INS) -  CAC/GL 36 -1989  The proposal for:  
ÿ a new revision; or  
ÿ revising an existing provision; or  
ÿ use and use levels of tocopherols (INS 
307a, b, c) as antioxidant in FC 01.3.1 
“Condensed milk (plain)) ”; or 
ÿ use and use levels of propylene glycil 
alginate (INS 405) and sucrose esters of 
fatty acis (INS 473) as emulsifier in FC 
05.1.4 “Cocoa and chocolate products ”. 
Food Category No. 
(2) Food Category Name (2) Maximum Use 
Level (3) Comments (4) 
    
    
    
    
Is the proposal related to a FC with corresponding commodity standards?  
(If yes indicate the relevant FC)  
 
 
 
Is the proposal also intended to revise the products covered by the commodity standards  
(If yes indicate the relevant commodity standards)  
 
 
EVALUATION BY JECFA:  
Evaluation by JECFA  
Reference to the JECFA evaluation (including 
year and JECFA session of evaluation; full ADI 
(numerical or “not specified ”); specifications 
monograph)   
JUSTIFICATION:  
Justification for use and technological nee d 
Supporting information based on the criteria in 
Section 3.2 of the Preamble of the  General 
Standard for Food Additives (i.e. has an 
advantage, does not present an appreciable 
health risk, serves a technological function).   
 
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Safe use of additive: Dietary intake 
assessment (as appropriate)  Table 3 additive:  
ÿ Yes 
ÿ No (Please provide information on dietary 
intake assessment below)  
 
Justification that the use does not mislead 
consumer   
 559 
(1)For proposed revisions of adopted pr ovisions,  the current adopted provision should be 560 
provided, with deletions noted in strikethrough text, and changes or additions noted in bold 561 
font. 562 
(2)Food Category number and name, as listed in Annex B of the GSFA.  563 
(3)For consistency, the maximum use level should be reported on the same basis as the 564 
ADI. A numerical use level should be provided for a food additive assigned a non - 565 
numerical ADI. GMP or a numerical use level may be provided for a food additive 566 
assigned a non -numerical ADI (e.g. “not-speci fied).  567 
(4)Comments on specific restrictions on the use of the food additive to be included as Notes 568 
(e.g. limitation of use to specific products in a food category).  569 
 570 
 571 
 572 
 573 
  574 
 
Page 14 of 14 
  575 
 576 
 577 
ANNEX C  578 
 579 
List of Repealed DOH/ FDA Issuances  580 
 581 
 582 
 583 
 584 
1. Administrative Order (AO) 88 -A s. 1984 refers to Regulatory Guidelines 585 
Concerning Food Additives  586 
 587 
2. Bureau Circular (BC) 2006 -0016  refers to Updated List of Food Additives  588 
 589 
3. Administrative Order (AO) 103 -A s. 1984  refers to Regulation on Non -nutritive 590 
Sweeteners Applicable to Both Food and Drug  591 
 592 
4. Administrative Order (AO) 112 s. 1985  refers to Regulation Governing 593 
Importation of Food Color Additives  594 
 595 
5. Administrative Order (AO) 122 s. 1970  refers to General Regulation Governing the 596 
Prohibition of the use of Cyclamic Acid and its Salts (B -6.3 Fo od Additives and 597 
Preservatives)  598 
 599 
 600 
 601 
 602 
 603 
 604