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DRAFT FOR COMMENTS  2 
as of 22 July 2019  3 
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[Date stamp here]  6 
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FDA Circular  8 
No. ____ ____ 9 
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SUBJECT:  GUIDELINES  ON THE REGISTRATION OF FOOD PRODUCTS , INCLUDING 11 
RAW MATERIALS  AND  FOOD INGREDIENTS , CONTAINING ALUMINUM 12 
LAKE COLORS , AND AS SUCH AS FOOD ADDITIVES FOR FURTHER 13 
PROCESSING     14 
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I. BACKGROUND  17 
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Colors are added to foods in many countries of the world, but the type of colorants permitted 19 
for use varies greatly among countries. Since international trade is becoming increasingly 20 
important, color legislation i s now of international concern. Unfortunately, a worldwide list of 21 
permitted color additives does not exist; therefore, color additives have, in some instance, 22 
become trade barriers for foods.  23 
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Based on Bureau Circular No. 2006 -016 or the Updated List of F ood Additives  from the List in 25 
Administrative Order No. 88 -A s. 1984  or Regulatory Guidelines Concerning Food Additives , 26 
it adopts the latest Codex Alimentarius General Standard for Food Additives  (Codex GSFA) as 27 
additional items not listed in BC 2006 -016. Aluminum Lake Colors are not listed in the GSFA 28 
nor in FDA AO No. 88 -A and BC No. 2006 -016.  29 
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Bureau Circular  No. 2006 -016 underwent WTO notification prior to its finalization through the 31 
Department of Trade and Industry – Bureau of Philippine Standards a s Philippine Contact 32 
Point for the Technical Barrier to Trade Notifications, where member countries were given the 33 
chance to comment on the said issuance.  34 
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Aluminum Lake Colors are included in the Combined Compendium of Food Additive 36 
Specifications, FAO JE CFA  (Joint FAO/WHO Expert Committee on Food Additives) 37 
Monographs for its general specifications, with an established Provisional Tolerable Weekly 38 
Intake (PTWI) of 2 mg/kg body weight for aluminum . Aluminum Lake Colors are prepared 39 
under aqueous conditions  by reacting aluminum oxide with coloring matter (straight dye). The 40 
resulting compound gives out a more pronounced color than that of the straight dye and that 41 
unreacted  aluminum oxide may also be present in the final product.  42 
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Rule 9b.1 of the Implementi ng Rules and Regulations (IRR) of the Food Safety Act of 2013 44 
states that “Codex standards shall be adopted except when these are in conflict with what is 45 
necessary to protect consumers and scientific justification exists for the action taken.” While 46 
stand ards other than Codex  may be adopted subject to certain conditions, specifically, Rule 47 
9b.2 of the same IRR, provides that the adoption of standards other than Codex shall be based 48 
on risk assessment . Hence, in order to formally adopt standards other than Codex , risk 49 
assessment must be done .  50 
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 Currently, the Center for Food Regulation and Research is approving applications for 1 
registration of food products with Aluminum Lake Colors which started in 2017 to give the 2 
affected food industry a two -year period  to reformulate their food products. However, it also 3 
set for a deadline on September 2019 for the approved applications for registration on food 4 
products with lake colors. Said deadline was reflected as part of the Remarks found at the 5 
bottom part of the Certificate of Product Registration, a s a temporary measure to address 6 
registration applications while waiting for Codex inclusion of Aluminum Lake Colors in the 7 
General Standard for Food Additives in two years’  time. There is no formal memorandum or 8 
advis ory issued to that effect. Consequently, there has been a clamor for the affected industry 9 
that such regulation can be a possible barrier to trade.  10 
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Initially, the  Food and Drug Administration  (FDA ) issued FDA Advisory No. 2019 -037 on the 12 
Use of Color Addi tives in Food Products  dated 20 February 2019. The Advisory sought to 13 
clarify that it has not issued any ban on the use of color additives in food products registered 14 
with the Agency, or implemented any new regulation restricting its use in food products.  15 
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Consistent with the FDA mandate to assure safe and quality food products as stated in 17 
Republic Act (RA) No. 9711 or the Food and Drug Administration Act of 2009 and its 18 
Implementing Rules and Regulations (IRR), as well as provisions stated in RA No. 10611  or 19 
the Food Safety Act of 2013 and its IRR, this FDA Circular  is hereby issued to serve as guide 20 
to all food manufacturers, importers and distributors  of processed food products containing 21 
Aluminum Lake Colors , in particular, and the general public, at la rge; and to demonstrate 22 
compliance to food safety and quality prior to issuance of FDA authorizations.   23 
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II. DIRECTIVES  25 
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A. The Aluminum Lake Colors in processed food products , including raw materials, food 27 
ingredients, is allowed for use  on conditions , as stated  in the proceeding provisions , are 28 
met upon filing of initial  Certificate of Product Registration (CPR) application or for 29 
renewal.  30 
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B. Additional requirements to be submitted by applicants upon renewal or initial 32 
application, with regards to the application of CPR for food products containing 33 
Aluminum Lake Colors, are as follows :  34 
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1. Presentation of r esults o f the conduct of Dietary Exposure Assessment to ensure that 36 
consumption of food products  containing Aluminum Lake Colors both in retail and in 37 
food service  do not exceed the established Provisional Tolerable Weekly Intake 38 
(PTWI) for such product at 2 mg/kg  body weight ( bw) aluminum as set by the Joint 39 
FAO/WHO Experts Committee on Food Additives (JECFA) as against the Food 40 
Consumption Data of the Filipino pop ulation  on a particular food product  at 55 kg 41 
body weight, an average weight assumed for the adult Asian population. (CAC/GL3 - 42 
1989; EHC Chapter 6, p.42) . 43 
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It is noted that Aluminum Lake Colors are considered safe by JECFA, if total 45 
exposure (from across al l food sources) falls within the PTWI of 2  mg/kg for 46 
aluminum that was established at the 74th JECFA in  2011.  47 
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2. Presentation of certificate of analysis based on the JECFA General  Specifications of 49 
Aluminum Lakes of Coloring Matters , for its purity and ident ity for pure Aluminum 50 
Lake Colors  for further processing . 51 
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 C. Furthermore, t he conduct of the Dietary Exposure Assessment (DEA) in Section II.B.1 1 
above would be an interim measure  until complete risk assessment of Aluminum Lake 2 
colors specific to the Filipino  population will be established ; and shall be based on the 3 
Codex Guidelines for the Simple Evaluation of Dietary Exposure to Food Additives  4 
(CAC/GL3 -1989, Adopted 1989, Revision 2014 or latest) , see Annex A.  5 
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Based on the said Guidelines, Dietary Exposure  Assessment combines food consumption 7 
data and the concentration of the food additive in food. The resulting dietary exposure  8 
estimate may then be compared with the ADI for the food additive [or the PTWI for 9 
aluminum lake color in this case ].  10 
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Three elem ents must be taken into account in assessing the dietary exposure to a food 12 
additive, as stated in the same Guidelines:  13 
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1. The concentration of the food additive in food ; 15 
2. The amount of food consumed; and  16 
3. The average body weight  17 
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Dietary exposure = Ʃ (Concent ration of food additive in food x Food Consumption)  19 
     Body weight (kg)  20 
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In lieu of actual consumption data from national surveys, to  determine DEA, annual food 22 
product sales volume, food balance sheet , food disappearance data or total diet studies  (if 23 
available) may be considered to approximate consumption and eventually establish a 24 
Theoretical Maximum Daily Intake (TMDI) and thus arrive at dietary exposure.  25 
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Food Consumption =  Sales volume for a year    28 
                         365 days           / 29 
       National Population  30 
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Thus,  32 
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PTWI  = Ʃ Dietary exposure x 7 days   34 
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D. The provision currently appearing on issued  CPR with regards to the deadline on 38 
acceptance of the application for registration of food products with aluminum lake color s 39 
shall be lifted. Processed food products with lake colors should satisfy requirements of 40 
this Circular. The safety of the food products should not be compromised such that the 41 
Food Business Operators shall be primarily responsible for the safety of food products 42 
including those  in the food service, that are offered for sale to the consumers .  43 
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E. Aluminum Lake Colors banned from other countries due to safety issues  are 45 
automatically not permitted to be registered in the Philippines as well as its use in any 46 
food product, i.e. Aluminum Lake form of FD&C Red No. 3 or Erythrosine .  47 
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F. Use of aluminum lake colors on processed food products (raw materials , food 49 
ingredients, food additives, and finished products) which are exclusively distributed for 50  
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 export market on ly shall be allowed , without the above stated requirements, provided that 1 
such use is permitted in the regulations of the importing country. The CPRs to be issued 2 
shall indicate “For export market only.”  3 
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G. All existing applications of products containing al uminum lake colors shall be processed 5 
based on the requirements of this Circular.  6 
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H. This measure will be in effect immediately unless proof of the safety of the processed 8 
food products containing aluminum lake color/s is established with supporting 9 
documen ts upon filing or refiling of CPR applications.  10 
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ROLANDO ENRIQUE D. DOMINGO , MD, DPBO  13 
                                                                              Unders ecretary of Health   14 
          Officer -in-Charge, Director General  15 
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DTN: 2019061016094 6 17 
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 ANNEX A 1 
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GUIDELINES FOR THE SIMPLE EVALUATION OF  3 
DIETARY EXPOSURE TO FOOD ADDITIVES  4 
(CAC/GL3 -1989, Adopt ed 1989, Revision 2014 ) 5 
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