Ver18112021  
 
 
Page 1 of 7 
  
[Date  Stamped]  
 
ADMINISTRATIVE  ORDER  
No. ______________________  
 
 
SUBJECT :  Guidelines on the Use of Cyclamates Repealing  Administrative Order No. 
122 series of 1970 entitled  “General Regulation Governing the Prohibition 
of the Use of Cyclamic Acid and its Salts (B -6.3. Food Additives and 
Preservatives) ” 
 
 
I. RATIONALE  
 
  On August  14, 1970,  the then Secretary  of Health  issued  Administrative  Order  
(AO)  No. 122  series  of 1970,  with Subject  General  Regulation  Governing  the Prohibition  
of the Use of Cyclamic  Acid  and Its  Salts  (B-6.3 Food  Additives  and Preservatives).   
 
 The Codex  Alimentarius  Commission  was created  by the Food  and 
Agriculture  Organization  (FAO)  and the World  Health  Organization  (WHO)  to protect  
the health  of consumers  and ensure  fair practices  in international  trade  of food through  
the development  of food standards,  codes of practice,  guidelines and other  
recommendations.  From the 2012 amendment of CODEX  STAN  192-1995  on the 
Additives  Permitted  for Use under  Specified  Conditions  in Certain  Food  Categories  
or Individual  Food  Items,  cyclamates  consisting  of cyclamic  acid, sodium cyclamate, 
and calcium  cyclamate  are listed  under  the Codex  General  Standard  for Food  Additives  
(GSFA).  Moreover, t he 71st Report of the  Joint  FAO/WHO  Expert Committee  on Food  
additives  (JECFA)  on its Safety  Evaluation  of Certain  Food  Additives  that included  
Cyclamic  Acid  and its Salts:  dietary  exposure  assessment , WHO  Technical  Report  
Series  956, 2010  has already addressed the issues  on its use.   
 
 Hence,  with the current  scientific  information  on cyclamic  acid and its salts 
provided  for use as food additives  under  specified  maximum  levels  in certain  food 
categories  or individual  food items  (Annex  A); emergence  of product  innovation s; as 
well as access  to global  trade,  the repeal  of Administrative  Order  No. 122 s. 1970  
becomes imperative.  
 
II. OBJECTIVES  
 
1. To allow the use of cyclamic acid and its salts as food additives by lifting the ban as 
provided by Administrative Order No. 122 s. 1970.  
 
2. To provide regulatory guidelines to food processors, importers, traders, distributors, 
wholesalers, manufacturers, an d other food business operators  on the safe and proper 
use of cyclamates as food additives with the setting of maximum use levels  in certain 
food categories or individual food item.  
 
3. To ensure regulatory compliance from the industry and effective enforceme nt by 
providing regulatory agencies with technical and scientific reference standard of safety Ver18112021  
 
 
Page 2 of 7 
 of cyclamates with proper use.  
 
III. SCOPE  
 
This Administrative  Order  covers  all cyclamates  listed under  the latest Codex  GSFA.  
 
IV. DEFINITION OF TERMS  
 
1. 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  (60 kg-man),  that can be  
ingested  daily  over a lifetime  without  appreciable  health  risk.1  (Codex  Stan 192 -
1995  Rev. 2012, (WHO  Environmental Health Criteria  No. 70, 1987).  
 
2. Cyclamate s refer to  cyclamic  acids and its sodium and  calcium  salts. 
 
3. FAO refers to  the Food and Agriculture Organization . 
 
4. 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 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.  
 
5. JECFA  refers to the Joint FAO/WHO Experts Committee on Food Additives . 
 
6. Maximum Level or Maximum Use Level  of an additive refers to the highest 
concentration of the food additive determined to be functionally effe ctive 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.  
 
The maximum use level will not usually correspond to the optimum recommended, or 
typical level of use. Under GMP, the optimum, recommended, o r 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, considering  the type 
of raw material, food processing and post -manufacture stor age, transport and handling 
by distributors, retailers, and consumers.  
 
7. WHO  refers to the World Health Organization . 
 
V. GUIDELINES  
 
To ensure safe and proper use of cyclamates as food additives, the following guidelines 
are hereby  issued for compliance:  
 
1. The Food and Drug Administration (FDA) adopts the Codex standard of use of 
cyclamates as shown in Annex A of this Administrative Order. Food business operators  Ver18112021  
 
 
Page 3 of 7 
 should  adhere to the Codex standard on the permissible maximum level under specified 
conditions in certain food categories.  
 
2. Updated values and information adopted by the Codex Alimentarius Commission shall 
be automatically included or adopted as an addendum to the attached Annex A on 
Cyclamic Acids and its Sodium and Calcium Salts.  
 
3. Food processors of pre -packaged food products  that uses any of the cyclamates are 
directed to declare the use of such non-nutritive sweetener and  to indicate  the 
appropriate function as food additive , i.e. sodium cyclamate (sweetener).  
 
4. Manufacturers, distributors, and tr aders of cyclamates  are directed to secure  FDA  
License to Operate (LTO) and Certificate of Product Registration (CPR) as food 
additives.  
 
5. All food additives subject to the provisions of this Order shall be used under the 
conditions of good manufacturing pr actice, which include the following:  
 
5.1. The quantity  of the additive added to food shall be limited to the lowest possible 
level necessary to accomplish its desired effect;  
 
5.2. The quantity of the food additive that becomes a component of food as a result 
of its use in the manufacturing, processing or packagin g 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,  
 
5.3. The additive is of appropriate food grade quality and is prepared and handled in 
the same wa y as a food ingredient.  
 
6. In case ambulant vendors or other food establishments opted to use cyclamates as a 
non-nutritive sweetener , only FDA  registered  cyclamates  shall be used  at levels 
prescribed in this Order . 
  
7. The Department of Interior and Local Gov ernment (DILG) and the Local Government 
units (LGUs) shall be provided with this AO for proper implementation as provided 
by Section 15 of Republic Act No. 10611, otherwise known as the Food Safety Act of 
2013.  
 
VI. PENALTY CLAUSE  
 
Violations to any provisions  of this Order shall be subject to the 
penalties/sanctions provided by Republic Act No. 10611, Food Safety Act of 2013 and 
other penalties provided by other applicable laws.  
 
VII. SEPERABILITY  CLAUSE  
 
If any provision of  this Order is declared unauthorized or rendered invalid by any 
court  of law or competent authority, those provisions not affected thereby  shall remain 
valid and effective.  
 Ver18112021  
 
 
Page 4 of 7 
 VIII.  REPEALING CLAUSE  
 
Administrative Order No. 122 s. 1970, with  Subject: “General Regulation 
Governing the Pr ohibition of the use of Cyclamic Acid and its Salts (B -6.3. food Additives 
and Preservatives)”, all orders, rules, regulations, and other related issuances inconsistent 
with or contrary to this Order are hereby repealed, amended, or modified accordingly.  
 
All provisions of existing issuances which are n ot affected by this Order shall 
remain valid and in effect.  
 
IX. EFFECTIVITY  
 
This Order shall take effect within fifteen (15) days after its publication in a 
news paper of general circulation and upon filing at the Office of the National 
Administrative Register (ONAR), University of the Philippines Law Center, Diliman, 
Quezon City.  
 
 
 
FRANCISCO T. DUQUE, III, MD  
Secretary of Health  
 
 
 
DTN 20191128154017  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Ver18112021  
 
 
Page 5 of 7 
  
Annex A  
 
Cyclamic Acid and its Sodium and Calcium Salts  
Permitted for Use Under Specified Conditions  
In Certain Food Categories or Individual Food Items1 
 
Food  
Category  
No. Food  Category  Maximum  
Level  
(mg additive/kg  
of food)  Note  Number  
 
(see last page  for 
details)  
01.1.4  Flavored fluid  milk drinks  250 mg/kg  17 &  477 
01.7 Dairy -based  desserts  (e.g. pudding,  fruit 
or flavored  yoghurt)  250 mg/kg  17 &  477 
02.4 Fat-based desserts excluding dairy - 
based  dessert  products  of food category  
01.7 250 mg/kg  17 &  161 
03.0 Edible Ices, including  sherbet  and sorbet  250 mg/kg  17 &  477 
04.1.2.4  Canned  or bottled  (pasteurized)  fruit 1,000 mg/kg  17, 161 &  
XS319  
04.1.2.5  Jams,  jellies,  marmalades  1,000 mg/kg  17 &  477 
04.1.2.6  Fruit -based spreads (e.g. chutney)  
excluding  products  of food category  
04.1.2.5  2,000 mg/kg  17 &  477 
04.1.2.8  Fruit  preparations,  including  pulp,  
purees,  fruit toppings  and coconut  milk 250 mg/kg  17 &  477 
04.1.2.9  Fruit -based  desserts,  including  fruit- 
flavored  water -based desserts  250 mg/kg  17 &  477 
04.2.2.6  Vegetable  (including  mushrooms  and 
fungi,  roots  and tubers,  pulses  and 
legumes, and aloe vera), seaweed, and  
nut and seed pulps  and preparations  
(e.g.,  vegetable  desserts  and sauces,  
candied  vegetables)  other  than food 
category  04.2.2.5  250 mg/kg  17 &  161 
05.1.2  Cocoa  mixes  (syrups)  250 mg/kg  17, 127 &  161 
05.1.3  Cocoa -based  spreads,  including  fillings  500 mg/kg  17, 477 &  XS86  
05.1.4  Cocoa  and chocolate  products  500 mg/kg  17 &  477 
05.1.5  Imitation  chocolate,  chocolate  substitute  
products  500 mg/kg  17 &  161 
05.2 Confectionery  including  hard and soft 
candy,  nougats,  etc. other  than food 
categories  05.1,  05.3 and 05.4 500 mg/kg  17, 156, 477 &  
XS309R  
& 161 
05.3 Chewing  gum 3000 mg/kg  17 &  477 
 
 
__________________________  Ver18112021  
 
 
Page 6 of 7 
 1 CODEX STAN 192 -1995, Rev 2019, Codex General Standard for Food Additives.  
05.4 Decorations  (e.g.,  for fine bakery  
wares),  toppings  (non-fruit)  and sweet  
sauces  500 mg/kg  17 &  477 
06.5 Cereal  and starch -based  desserts  (e.g.,  
rice pudding,  tapioca  pudding)  250 mg/kg  17 &  161 
07. 2  Fine bakery  wares  (sweet,  salty,  
savoury)  and mixes  1600 mg/kg  17 &  165 
10.4 Egg-based  desserts  (e.g., custard)  250 mg/kg  17 &  477 
11.4 Other  sugars  and syrups  (e.g.,  xylose,  
maple  syrup, sugar toppings)  500 mg/kg  17 &  159 
11.6 Table -top sweeteners,  including  those  
containing  high intensity  sweeteners  GMP  17 
12.6.1  Emulsified  sauces  and dips (e.g.,  
mayonnaise,  salad  dressing,  onion  dip) 500 mg/kg  17 &  161 
12.7 Salads  (e.g.,  macaroni  salad,  potato  salad) 
and sandwich spreads excluding  cocoa - 
and nut-based  spreads  of food 
categories  04.2.2.5  and 05.1.3  500 mg/kg  17 &  161 
13.3 Dietetic  foods  intended  for special  
medical  purposes (excluding  products  of 
food category  13.1)  400 mg/kg  17 
13.4 Dietetic  formulae  for slimming  purposes  
and weight  reduction  400 mg/kg  17 
13.5 Dietetic  foods  (e.g.,  supplementary  foods  
for dietary  use) excluding  products  of 
food categories  13.1 - 13.4 
and 13.6 400 mg/kg  17 
13.6 Food  supplements  1250 mg/kg  17 
14.1.3.1  Fruit  nectar  400 mg/kg  17 &  122 
14.1.3.2  Vegetable  nectar  400 mg/kg  17 &  161 
14.1.3.3  Concentrates  for fruit nectar  400 mg/kg  17, 122 &  127 
14.1.3.4  Concentrates  for vegetable  nectar  400 mg/kg  17, 127 &  161 
14.1.4  Water -based  flavoured  drinks,  including  
"sport,"  "energy,"  or "electrolyte"  drinks  
and particulated  drinks  350 mg/kg  17 &  127 
14.2.7  Aromatized  alcoholic  beverages  (e.g.,  
beer,  wine  and spirituous  cooler -type 
beverages,  low alcoholic refreshers)  250 /kg 17 
 
 
 
 
 
 
 
 
 
 
 Ver18112021  
 
 
Page 7 of 7 
  
Notes to the Comments  
 
Note  17 As cyclamic  acid 
Note  122 Subject  to national  legislation  of the importing  country.  
Note  127 As served  to the consumer.  
Note  156 For use in micro -sweets  and breath  freshening  mints  at 2 500 
mg/kg.  
Note  159 For use in pancake  syrup  and maple  syrup  only.  
Note  161 Subject  to national  legislation  of the importing  country  aimed,  in 
particular, at consistency  with Section  3.2 of the Preamble.  
Note  165 For use in products  for special  nutritional  use only.  
Note  477 Some  Codex  Members  allow  use of additives  with sweetener  
function  in all foods  within  this Food  Category  while  others  limit  
additives  with sweetener  function  to those  foods  with significant  
energy  reduction or  no added sugars.  
Note  XS86  Excluding  products  conforming  to the Standard  for Cocoa Butter  
(CODEX  STAN  86-1981).  
Note  XS309R  Excluding  products  conforming  to the Codex  Regional  Standard  
for Halawa  Tehenia (CODEX  STAN  309R -211).  
Note  XS319  Excluding  products  conforming  to the Standard for  Certain  
Canned  Fruits  (CODEX STAN  319-2015).  
 