Imported Foods - Food and Color Additives
Issued May 3, 2001

CHAPTER 09 - FOOD AND COLOR ADDITIVES

IMPORTED FOODS - FOOD AND COLOR ADDITIVES

OCTOBER 1, 2000
SEPTEMBER 30, 2003

Note: (*) Indicates changes/revisions

All Food Codes *(except industry 16, Seafood and Industry 50 (Color Additives)*	09006A Food Additives
All Food Codes *(except industry 16, Seafood and Industry 45-46 (Food Additives)	09006B Color Additives
Additional related PAC Codes:	*03R833 (Entry Review)* *99R833 (Filer Evaluation)* *04R824 (Follow-up to Refusal)*

FIELD REPORTING REQUIREMENTS

1. Hardcopy

   No hardcopy reporting will be required for this program.

2. FIS Reporting

Report all analytical results into the Field Activity Compliance Tracking System (FACTS).

*INTERACTION WITH OTHER PROGRAMS/ASSIGNMENTS*

• Import Acidified and Low-Acid Canned Foods Program, see CP 7303.003
• Import Pesticides and Industrial Chemicals in Imported Foods, see CP 7304.016
• Domestic and Imported Cheese, see CP 7303.037
• Imported Seafood Products, see CP 7303.844
• NLEA Enforcement – Imports, see CP 7321.007
• Imported Cosmetic Compliance Program, see CP 7329.002

PART I - BACKGROUND

Imported food products must comply with all provisions of the Federal Food Drug & Cosmetic Act (FFD&C Act), including the regulations for food and color additives. This program directs sample collection and examination of samples of imported foods for unsafe/undeclared food additives, non-permitted/unlisted or undeclared color additives, and food and color additives otherwise used in a manner not in compliance with applicable regulations.

* With passage of the Nutrition Labeling and Education Act (NLEA) and implementing regulations, the declaration of all certifiable color additives is now required. There are a few exceptions; for example butter, cheese, and ice cream are exempt from certified color labeling requirements except for FD&C Yellow No. 5 and No. 6. (See CFR 101.22(k) for additional details). The exception for FD&C Yellow No. 6 is pending promulgation of a final rule. *

Past food and color additives problem areas (some of which are addressed in specific Import Alerts) include the following:

• Sulfites in shrimp, dried fruits and vegetables, and other fresh or processed foods
• Non-permitted cyclamates in mixed fruit products
• Lack of the required saccharin warning statement on the label of a finished food.
• Attempted importation of betel nuts for commercial distribution.
• Coumarin in "vanilla" products
• Nitrosamines in barley malt, malt beverages, or rubber baby bottle nipples.
• Non-permitted/unlisted colors in candies, processed fruit and vegetable products, soft drinks, and bakery products (e.g., Amaranth (formerly certifiable as FD&C Red No. 2), Azorubine (formerly certifiable as Ext. D&C Red No. 10), Xylene Red B (no certifiable equivalent), Ponceau 4R(no certifiable equivalent), and Rhodamine B (C.I. 45170, Chloride and stearate salts formerly certifiable as D&C Red No. 19 and D&C Red No. 37)
• Undeclared benzoates in beverages and bamboo shoots
• Undeclared sorbates in salad dressing
• Undeclared nitrates/nitrites in fishery products

NOTE: Seafood products are covered under the Import Seafood Products CP7303.844.

FD&C Red No. 3 is currently permitted for use in foods only when used in the form of the straight color additive. All "lakes" of this color additive are not permitted in foods manufactured on/or after January 29, 1990. See Part V for regulatory guidance concerning products found to contain FD&C Red No. 3.

Sulfiting agents as chemical preservatives in food products are excluded from use on foods in the following categories:

• Fruits or vegetables intended to be served raw to consumers or sold raw to consumers, or to be presented to consumers as fresh.
• Foods recognized as a source of vitamin B₁
• Meats

The use of sulfiting agents as chemical preservatives in foods (other than the aforementioned categories) is GRAS when used in accordance with GMPs. However, a sulfiting agent used as a preservative and/or present in food at levels that will have a functional or technical effect, must be declared on the label. Sulfites present as incidental additives (with no functional or technical effect) at 10 ppm or greater must be declared.

See CP 7304.016 - Pesticide and Industrial Chemicals in Imported Foods for guidance concerning the fungicidal use of sulfites on table grapes (DO NOT use PAC 09006A for the fungicidal use of sulfites).

Part II - IMPLEMENTATION

OBJECTIVES

• To collect and examine imported foods to determine if they are in compliance with the requirements of the FD&C Act and the regulations concerning food and color additives.
• To prevent the introduction of imported foods into interstate commerce that are found to be out of compliance.
• *To utilize the Import Alert procedures outlined in Chapter 9 of the Regulatory Procedures Manual (RPM) to detain without physical examination/analysis future entries of products found to be out of compliance. *

PROGRAM INTERACTION

• Import Acidified and Low-Acid Canned Foods Program, see CP 7303.003
• Import Pesticides and Industrial Chemicals in Imported Foods, see CP 7304.016
• Domestic and Imported Cheese, see CP 7303.037
• Imported Seafood Products, see CP 7303.844
• NLEA Enforcement – Imports, see CP 7321.007
• Imported Cosmetic Compliance Program, see CP 7329.002

PART III - INSPECTIONAL

1. Inspectional

No inspections are scheduled under this program.

2. Import Sample Collection

1. General

Conduct sample collections of imported food products having a known or suspected potential for food and color additive violations. Conduct label reviews of imported food products for potential food and color additive violations as established by the current fiscal year workplan. Base sample selection on District experience plus the historical information in PART I - BACKGROUND of this program.

Refer to Regulatory Procedures Manual, Chapter 9, for procedural guidelines. Import Alerts and Import Bulletins accessed via the FDA Import Alerts Retrieval System (FIARS) on the District office VAX will be changed over to the Operational and Administrative System for Import Support (OASIS) system. Please contact DIOP’s Systems Branch for further information on this change over at (301) 443-6553.

Searchable Import Alerts, Import Bulletins and the Investigations Operations Manual (IOM) are accessible via the ORA/DIOP Intranet site. *The current Import Alert for color additives in food products (e.g. Import Alert 45-02) is currently under review for possible clarification/revision. *

Refer to the current edition of the Investigations Operations Manual (IOM) Appendix A, Food Additive and Color Additive Status Lists.

2. Sample Size

Consult Sample Schedule Charts in Chapter 4 of the current edition of the IOM for specific sample size for food additives. If information on the commodity of interest is not available there, check appropriate DEIO Guide to Inspection Manuals, for correct sample size. If hard copy is unavailable, these guides are available on the ORA web site at the following address: http://www.fda.gov/ora/inspect_ref/default.htm. IOM Sample Schedule Chart 9 provides additional guidance for color containing products.

In most cases, the size of a sample collected for filth analysis will be sufficient for food and color additive analysis as well. However, in some cases, it may be necessary to consult with the analyzing laboratory on the amount of sample required for analysis of specific food additives.

3. Sample Shipment

Submit all samples for food and color additive(s) analysis to your District’s servicing laboratory. Contact CFSAN/DOEP/Imports Branch before collecting samples for N-nitrosamines analysis. CFSAN’s Office of Premarket Approval, Division of Product Manufacture and Use (OPA/DPMU) may recommend a Mass Spectrometry(MS) method for use by a field lab or may identify a private laboratory for testing. Testing for N-nitrosamines is expected to be very limited. ORA will explore options for developing laboratory test capabilities. See PART IV - ANALYTICAL for designated laboratories for food additives and color additives.

4. *Sample Flag*

The following Program Area Flags (PAF) should be used to identify attributes to be analyzed for samples collected:

• Color Additive – PAF: COL
• Food Additives – PAF: FAD
5. *Entry Reviews*

Operational time spent on Entry Reviews for this program should be reported under PAC code 03R833

6. *Filer Evaluation*

Operational time spent on Filer Evaluation for this program should be reported under PAC code 99R833

7. *Follow-up to Refusals*

Operational time spent on Follow-up to Refusals of entries due to color and/or food additive violations, should be reported under PAC code 04R824

PART IV - ANALYTICAL

1. Analyzing Laboratories
   1. Food Additives - * Northeast Region, PHI-DO, BLT-DO and CIN-DO to NRL
      Southeast Region to SRL
      SWR to DEN-DO Lab
      PAR to SAN-DO Lab
      CHI-DO, DET-DO and MIN-DO to ARL *

      *For additional information on Servicing Laboratories, please refer to Servicing Laboratory Table found in Part I, Appendix III of the current fiscal year ORA Field Workplan. *

      • Analysis for antioxidants in fats and oils (BHA, BHT, Ionox-100, NDGA, TBHQ, THBP, and Propyl Gallate) will be performed by the following laboratories: NRL and DEN-DO
      • *Analyses for N-nitrosamines. Contact CFSAN/DOEP/Imports Branch before collecting samples for N-nitrosamines analysis. CFSAN/OPA/DPMU may recommend a Mass Spectrometry method for use by a field lab or may identify a private laboratory for testing. *

   2. Color Additives - * Same as food additives servicing laboratories. *

2. Analytical Methodology

Use methodology appropriate for the product as well as the additive for which the product is being tested. Various analytical methodology sources are currently available for food additives and food additive combinations in addition to those listed below. Consult with the CFSAN Analytical Contact prior to analysis if there are questions about the appropriate methodology. * Please refer to section 2.3.3.1 (Chapter 2) of the Laboratory Procedures Manual for instances where a check analysis is necessary. *

1. Food Additives

• AOAC, Official Methods of Analysis, 17^th Edition, Chapters 47 and 48. *Or the most current AOAC edition. *
• Food Additives Analytical Manual, Vol. I and II, 1983 and 1987
• Food Chemicals Codex, 4^th Edition, * or earlier editions as referenced in the appropriate regulations in 21 CFR 170-199. *
• Antioxidants in Fats and Oils: AOAC 16^th Edition, (983.15), *or most current edition. *
• LMS Code Manual Appendix S for food additives. *Please note that FACTS version 2 will replace the LMS system. Appendix S information will be available as part of the FACTS data entry system. *
• Sulfites - AOAC 16^th Edition, (990.28), Optimized Monier-Williams Method. (Final Action, 1994) Monier-Williams titrimetric results with gravimetric confirmation must be used to provide either initial analysis or the check analysis. Other methods such as those found in a current edition of the AOAC Official Methods of Analysis may be used if the method is known to give results comparable to the values obtained with the Optimized Monier-Williams method. *
2. Color Additives

• * AOAC, Official Methods of Analysis, 17^th edition of AOAC, Chapter 46. Or most current edition of AOAC. *
• LMS Code Manual Appendix N for colors additives. *Please note that FACTS version 2 will replace the LMS system. Appendix N information will be available as part of the FACTS data entry system. *
• * Attempt to identify any non-permitted/unlisted color(s) present. If non-permitted/unlisted colors are found, a check analysis must be conducted. If one non-permitted/unlisted color is confirmed, identification of the remaining color components in the product is not necessary for initiating regulatory action. However, as resources permit, the identification and confirmation of the other color(s) present would improve the agency database concerning color usage abroad. The field should also be aware of the inappropriate use of certain color additives (i.e., the use of drug and cosmetic (D&C) or external drug and cosmetic (Ext. D&C) color additives in food products. *
• * NLEA requires the declaration of all certified color additives by name. If undeclared certifiable colors are found in a sample, perform a check analysis to confirm the presence of at least one undeclared certifiable color additive to support an adulteration charge (in the absence of evidence that the color is from a certified lot). If multiple undeclared certifiable color additives are found by original analysis, the district may exercise discretion with regard to performing check analysis for each color additive. For adulteration recommendations an original and check analysis must be performed for each color being recommended for Detention without Physical Examination (DWPE) consideration. *
• The original or check analyses for the identification of unlisted/non-permitted or undeclared color additives should always include visible spectra of the isolated color additive, ideally under acidic, basic, and neutral conditions. Standard reference spectra in the same solvent as those for the isolated color should be attached to the analytical worksheets. Confirmatory analyses should include different characterizing data (e.g., TLC R_f-values, HPLC retention times, etc.). TLC confirmation should include either tables of R_f-values, or high quality reproductions of the TLC plates with spots and streaks clearly encircled and labeled. The colors of the spots and streaks should also be reported, especially if black and white reproductions are submitted. In addition, spots should be checked under UV light. The presence or absence of fluorescence as well as the visual color of the fluorescence should be reported to support the identity of fluorescent dyes.*
• *A check analysis is not currently required for those analyses performed by the Field Color Expert located in Northeast Regional Laboratory (NRL) for either detention or DWPE recommendations. *
• Do not routinely quantitate the colors for which no limits have been established.
• * When samples are analyzed for color additives, it is imperative that the reports of analysis not convey erroneous information. Since no analytical method is capable of determining that a color additive in a food matrix is from a FDA certified lot, the conclusion should not state, for example, "contains FD&C Yellow No. 5". *We suggest the following language be used to more accurately describe a color additive that has not been shown to come from FDA certified color lots: Tartrazine (C.I. 19140, certifiable as FD&C Yellow No. 5). *

1. * The following color additives are not authorized for use in food products in the United States. *

• Amaranth (C.I. 16185, EEC No. E123, formerly certifiable as FD&C Red No. 2)
• Azorubine (C.I. 14720, EEC No. E122, formerly certifiable as Ext. D&C Red No. 10); also called Azo Rubine and Carmoisine.
• Dibromofluorescein (C.I. 45370:1 certifiable as D&C Orange No. 5).
• Eosine (the disodium salt, C.I. 45380, is certifiable as D&C Red No. 22. The lactone form, tetrabromofluorescein, C.I. 45380:2 is certifiable as D&C Red No. 21. The methodology does not distinguish these and other forms of Eosine.
• Eosin B (the disodium salt, C.I. 45400, and the lactone dibromodinitrofluorescein, have no certifiable equivalent
• Fast Crimson GR (C.I. 18050, (also known as C.I. Acid Red 1) formerly certifiable as Ext. D&C Red No. 11)
• Ponceau 4R (C.I. Acid Red No. 18, C.I. 16255, EEC No. E124, no certifiable equivalent). Also called Cochineal Red A, Brilliant Scarlet 3R and Brilliant Scarlet 4R, but not Brilliant Scarlet which is a different color (C.I. 15585:1, formerly certifiable as D&C Red No. 8).
• Quinoline Yellow (resembles C.I. 47005, EEC No. E104, C.I. Acid Yellow No. 3, C.I. Food Yellow 13). In the United States, primarily monosulfonated quinoline yellow is certifiable as D&C Yellow No. 10 for use in drug and cosmetics, but is not permitted in foods at this time. In European and other countries, primarily disulfonated quinoline yellow may be used as a color additive in foods. *
2. *The following color additives are authorized by regulation (see Title 21 Code of Federal Regulations (CFR) Part 74) for safe use in food products, only when the color additives are from batches that have been certified by the FDA:

FD&C Red No. 3, Citrus Red No. 2, FD&C Red No. 40, FD&C Blue No. 1, FD&C Blue No. 2, FD&C Green No. 3, Orange B, FD&C Yellow No. 5, and FD&C Yellow No. 6

*Analytically we cannot determine if a color additive subject to certification has in fact been certified. Analysts should report their findings of these colors as follows:*

• Allura Red AC (C.I. 16035, certifiable as FD&C Red No. 40)
• Brilliant Blue FCF (C.I. 42090, certifiable as FD&C Blue No. 1)
• Citrus Red No. 2(C.I. 12156, certifiable, for use only for coloring the skins of oranges that are not intended or used for processing)
• Erythrosine (C.I. 45430, the disodium salt is certifiable as FD&C Red No. 3)
• Fast Green FCF (C.I. 42053, certifiable as FD&C Green No. 3)
• Indigotine (C.I. 73015, certifiable as FD&C Blue No. 2)
• Orange B (C.I. 19235, for use only in coloring sausage casings)
• Sunset Yellow FCF (C.I. 15985, certifiable as FD&C Yellow No. 6)
• Tartrazine (C.I. 19140, certifiable as FD&C Yellow No. 5)

*Be aware of the presence and the possible separation of subsidiary and isomeric dyes, which are permitted in many of the FD&C colors (see 21 CFR Part 74). Their presence may be more evident when high-resolution techniques are employed such as HPLC and HPTLC. Excessively high levels of subsidiaries in tartrazine, Sunset Yellow FCF and Allura Red AC may indicate the use of non-certified batches of these dyes and should be noted as a possibility on the FACTS report. *

3. Analytical Reporting

• * Report all analytical results into the Field Activity Compliance Reporting System (FACTS) as appropriate or applicable using the following Problem Area Flags (PAF) and Program Assignment Codes (PAC).
• Color Additives --

  PAC 09006B
  PAF: COL

• Food Additives --

  PAC 09006A
  PAF: FAD

• Questions about entering data into FACTS should be directed to your District’s Lead FACTS User. *

PART V - REGULATORY/ADMINISTRATIVE STRATEGY

• * Unless otherwise instructed, do not release a sampled lot until the analyses are completed. Follow the guidance in the Regulatory Procedures Manual, Chapter 9. Districts are authorized to detain a sampled lot without analysis if the product labeling declares only an illegal (unlisted) food or color additive in the ingredient statement.
• In the case of imported food products, many products bear ingredient labels identifying colors with their European name or ("E") color designation with a corresponding number (e.g., E104, E122, E123, and E124), by using a color index number (e.g. C.I. 15985) or using the trade or common name of the color additive (e.g. Sunset Yellow FCF). This suggests that the color additives used may not be certified. When a food bears only the aforementioned designations; districts are authorized to detain products based on the appearance of adulteration (i.e., the product appears to contain an uncertified color additives) without any FDA laboratory analysis.
• If the filer/importer can show a copy of the FDA certificate for the batch and lot number of the color used, then we will release the entry provided that the importer changes the label to declare the color by the certified name such as FD&C Yellow No. 6 or Yellow 6. If the imported product contains undeclared colors, they will also have to show proof that the product contains only permitted colors. The appropriate charge for products that meet the above criteria is 402(c) adulteration. *
• * Certifiable color additives designated on ingredient declarations solely by names not matching the ones used in the acceptable nomenclature should be assumed to originate from non-certified color lots. These could include designations only by Color Index number, EEC number, trade name, common name, etc., without reference to the legal name, e.g. FD&C Yellow No. 6 or permitted abbreviations e.g., "Yellow 6". The appropriate charge for products that meet the above criteria is 402(c) - adulteration. Contact Mark Hackman, CFSAN/DOEP/Imports Branch (HFS-606) at (202) 205-8211 for guidance if special circumstances arise. When using the 402(c) and 801(a)(3)- adulteration charge, the term "undeclared", in conjunction with the name of the certified color additive should not be used. (e.g. "Contains undeclared FD&C Yellow No. 6") *
• * The fact that a undeclared color additive is certifiable does not automatically mean the color additive has been certified by FDA for use in food products since analytically we cannot determine whether a particular color subject to certification had been certified. Without evidence that the color came from a batch that has been certified (e.g., an FDA certification batch and lot number), the appropriate charge would be a 402(c) adulteration charge rather than simply a misbranding charge for failure to declare the color by its appropriate FD&C name. * If a filer/importer challenges the adulteration charge, Import Compliance should request that the importer provide conclusive evidence that the undeclared color came from an FDA certified batch.

Acceptable evidence would include photocopies of the FDA certificate that clearly show the batch and lot numbers and/or invoice(s) showing the purchase of a color additive from a certified source that includes the color certification batch and lot number.

• Refer to the Compliance Policy Guides (CPG) Manual, the Regulatory Procedures Manual, Import Alerts and Import Bulletins for guidance. Specific CPGs concerning food and color additives include the following:
• N-Nitrosamines

Section 510.600   Dimethylnitrosamine in Malt Beverages (CPG 7101.07)

Section 578.500   Dimethylnitrosamine in Barley Malt (CPG 7104.07)

Section 500.450   Volatile N-Nitrosamines in Rubber Baby Bottle Nipples (CPG 7117.11)

• Nitrates

Section 540.200   Chubs, Hot Process Smoked with Added Nitrite - Adulteration Involving Food Additives, Sodium Nitrite (CPG 7108.15)

Section 540.500   Tuna, Sable, Salmon, Shad - Smoked Cured, Adulteration Involving Food Additives, Sodium Nitrite (CPG 7108.18)

• Other Food Additives

Section 578.600   Unapproved Additives for Exported Grains (CPG 7104.08)

Section 500.200   Food Additives - "GRAS" (CPG 7117.12)

Section 510.200   Brandy Containing Methyl Alcohol - Food Additive (CPG 7119.09)

Section 457.100   Pangamic Acid and Pangamic Acid Products Unsafe for Food and Drug Use (CPG 7121.01)

• Color Additives

Section 550.625   Oranges - Artificial Coloring (CPG 7110.21)

Section 585.825   Sweet Potatoes - Dyeing of Yellow and Red Varieties (CPG 7114.26)

Section 545.200   Confectionery Decorations (Nutritive and Non-Nutritive) (CPG 7117.03)

Section 587.200   Uncertified or Delisted Colors in Foods for Export - (e.g., FD&C Red #2) (CPG 7127.02)

Section 587.300   Color Additives (CPG 7127.03)

FD&C Red No. 3 in imported foods - Only the straight dye is permitted for use in foods. If the investigator/inspector or analyst has reason to suspect that an imported product contains a lake of FD&C Red No. 3 (for example if there is a past violative history for the manufacturer/shipper/commodity), request additional information from the Broker/Importer. In these circumstances, the broker/importer should provide verification that the product contains only straight dye and not its lake. The broker/importer will have to provide the certification lot number for the FD&C Red No. 3. In cases where a lake of FD&C Red No. 3 is listed on the label, the product should be detained without analysis.

• Additives - labeling

Section 500.100   Additives - Labeling with Adequate Directions for Many Uses (CPG 7117.01)


Section 500.250   Food Additives - Labeling: Directions for Safe Use (CPG 7117.13)

Section 500.300   "Approved by FDA" - Use of Phrase Objectionable in Marketing or Labeling of a Food Additive (CPG 7117.09)

Section 555.800   Polysorbates 20, 40, 60, 65, 80, 85 - Common or Usual Names (CPG 7120.09)

Section 587.100   Label Declaration of Artificial Color (CPG 7127.01)

If an illegal color or food additive has been detected, in addition to detaining the specific entry, be sure to consider recommending an Import Alert covering the specific manufacturer and product. Such recommendations are to be routed to DIOP as instructed in the Regulatory Procedures Manual (RPM), Chapter 9. This chapter instructs, in part, that such a recommendation can be based on one sample if, "The product is violative in a way that is likely to continue due to the product’s ingredients or formulation. For example, products which bear or contain undeclared significant ingredients (i.e. human allergen), unapproved colors, or violate their applicable standard of identity …will continue to appear violative until the manufacturer of such products changes the label or formula for the product or obtains agency approval necessary for legal marketing."

PART VI - REFERENCES, ATTACHMENTS AND PROGRAM CONTACTS

REFERENCES

• Investigations Operations Manual (IOM) Current Edition:

Appendix A - Food and Color Additives Status List

• Regulatory Procedures Manual (RPM), Chapter 9
• * Import Alerts and Import Bulletins accessed via the FDA Import Alerts Retrieval System (FIARS) on the District office VAX will be changed over to the Operational and Administrative System for Import Support (OASIS) system. Please contact ORA/DIOP Systems Branch at (301) 443-6553 for further information on this change over. *
• Compliance Policy Guides Manual (CPGM)

PROGRAM CONTACTS

• General/Regulatory questions - * Mark Hackman, CFSAN/Division of Enforcement and Programs, Imports Branch, HFS-606, Telephone (202) 205-8211, Fax (202) 260-0208. *
• ORA/Division of Import Operations and Policy (HFC-170) contact: *Ted Poplawski Telephone (301) 594-3849, FAX (301) 594-0413*
• Analytical:

Food Additives - Dr. Gregory Diachenko, CFSAN, HFS-245, Telephone (202) 205-5320, FAX (202) 401-8531.

Color Additives - Dr. Sandra Bell, CFSAN, HFS-126, Telephone (202) 205-0291, FAX (202) 205-5098.

General Methods Contact - * George Salem, ORA/Division of Field Science, HFC-140, Telephone (301) 827-1031, FAX (301) 443-6388. *

VII - CENTER RESPONSIBILITY

The Director, Office of Premarket Approval, in coordination with the Director, Office of Cosmetics and Colors, is responsible for submitting annual evaluations of this program. The evaluation should be submitted to the Chief, CFSAN Imports Branch (HFS-606), by April 1 each fiscal year. Accomplishment data will be supplied on request.

Hypertext updated by cjm 2001-SEP-18