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GUIDANCE DOCUMENT

Guidance for Industry: Recommendations for Submission of Chemical and Technological Data for Direct Food Additive Petitions March 2009

Final
Docket Number:
FDA-2020-D-1922
Issued by:
Guidance Issuing Office
Human Foods Program

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.

Table of Contents

  1. Introduction
  2. Authority
  3. Recommendations for Petition Preparation
    1. Identity
    2. Manufacturing Process
    3. Specifications for Identity and Purity
    4. Stability of the Food Additive
    5. Intended Technical Effect and Use
    6. Methodology for Analysis of the Additive in Food
    7. Intake Estimate
  4. Additional Information and Requirements

I. Introduction

This document describes the types of chemical and technological data that FDA's Office of Food Additive Safety (OFAS) in the Center for Food Safety and Applied Nutrition (CFSAN) considers necessary for the evaluation of petitions seeking regulation for the safe use of direct food additives.

As prescribed by the Federal Food, Drug, and Cosmetic Act (the Act) and Title 21, Code of Federal Regulations [21 CFR] 170.3 (h)(i), food additives must be shown to be safe (i.e., to have a reasonable certainty of no harm) under their intended conditions of use before they can be intentionally added to food.  Food additives are currently categorized as direct additives, secondary direct additives,2 indirect additives,3 and sources of ionizing radiation.4  Section 201(s) of the Act exempts the use(s) of a substance that is generally recognized as safe (GRAS)5 from the definition of a food additive.  The CFR contains regulations for food ingredients that are listed or affirmed as GRAS.  This document is guidance for submitting a petition for a direct food additive (i.e., a substance added directly to food, as codified in 21 CFR Part 172).  Color additives, as codified in 21 CFR Parts 73 and 74, are not discussed in this document.6

This document is a revision of and supercedes, the guidance entitled "Chemistry and Technological Data for Direct Food Additive Petitions" dated March 2006. 

This guidance is intended to address needs for most petitions, but some recommendations may not be applicable in all cases.  If a recommendation does not appear to apply to the petitioned additive and use, the petitioner should explain briefly why the data recommended here are not needed to evaluate the safety or promulgate a regulation for the petitioned request.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in Agency guidances means that something is suggested or recommended, but not necessarily required. 

II. Authority: Statutory and Regulatory Requirements

Section 409(b)(2) of the Act describes the statutory requirements for food additive petitions.  Briefly, these encompass five general areas of information:

  1. The identity of the additive.
  2. The proposed use of the additive.
  3. The intended technical effect of the additive.
  4. A method of analysis for the additive in food.
  5. Full reports of all safety investigations with respect to the additive. 

In addition, the petitioner shall furnish, upon request, a complete description of the methods, facilities, and controls used in or for the production of the additive [Section 409(b)(3)] and/or samples of the additive and of food in which the additive will be used [Section 409(b)(4)].

21 CFR 171.1(c) describes in greater detail the data requirements for food additive petitions, including the five basic areas of information and scientific data noted above, as well as other administrative information, an environmental assessment, and specimens of proposed labeling.  This guidance document addresses only chemistry-related issues.

As described in 21 CFR 171.1(h), certain data and information contained in food additive petitions are available for public disclosure, while other data are not.  Questions in this regard should be directed to OFAS.7

III. Recommendations for Petition Preparation

A.  Identity

Information allowing the unequivocal identification and characterization of the food additive should be provided.  Such items include:

  1. Formal chemical name.  The Chemical Abstracts or IUPAC name of the additive is acceptable.
  2. Common names, synonyms, or trade names.
  3. Chemical Abstracts Service (CAS) Registry Number.  Providing CAS Registry Numbers for a petitioned food additive and for impurities in and degradation products of the petitioned additive can help OFAS further identify the chemicals intended to be added to food.  This facilitates the determination of exposure to and safety of the various chemicals present in food as the result of the use of the food additive.  CAS Registry Numbers for new compounds and assistance with nomenclature can be obtained by writing to the CAS Client Services, Chemical Abstracts Service, P.O. Box 3012, Columbus, OH, 43210-0012.
  4. Empirical and structural formulae, and molecular or formula weights.
  5. Composition of the food additive.  For mixtures, identify as many of the components as feasible to reasonably define the composition of the mixture.  In addition, information on the chemical composition and identity for each component in the mixture and a material balance should be provided.
  6. For food additives of natural origin, information on the source (e.g., systematic name, genus, species, variability based on climate or other geographical factors).
  7. Further characterizing information, such as data on chemical and physical properties of the food additive (e.g., melting point, boiling point, specific gravity, refractive index, optical rotation, pH, solubility, and reactivity), and chromatographic, spectroscopic or spectrometric data (e.g., spectra from nuclear magnetic resonance, infrared, electronic absorption, or mass spectra) that can be used as a "fingerprint" for identification should be submitted. If the particle size is important for the additive to achieve its intended technical effect, such that the additive is produced or processed using techniques or tools that manipulate the particle size and may contain altered particles that are formed as manufacturing by-products, data on the size (average and distribution), shape, surface area (average and distribution), surface charge (zeta potential), and morphology of the particles, as well as any other size-dependent properties (e.g., agglomeration, aggregation, dispersion) should be included, as appropriate.

In accordance with 21 CFR 171.1(c) A, where such information is not available, a statement as to the reasons why it is not available should be submitted.

B. Manufacturing Process

Information on the method of manufacture of a food additive is necessary for identification and characterization of both the intended component(s) and any likely impurities (e.g., residual starting materials, products of side reactions, and decomposition products of reactants or of the additive) in the additive.  For food additives of natural origin that might contain known toxicants, the petitioner should address the ability of the manufacturing process to control, reduce, or concentrate toxicant levels.

A discussion of the manufacturing process should include a list of the reagents, solvents, catalysts, processing aids, purification aids, specialized equipment, etc. used, as well as a detailed description of the process itself, including all reaction conditions (e.g., time, temperature, and pH) and production controls (including steps taken to limit the presence of reaction by-products and other impurities).  The petitioner should also identify any alternative method(s) of manufacture of the additive, if known, and provide as full a description as possible for the method.  In all cases, the manufacture of the additive should be consistent with good manufacturing practice (GMP; discussed below in Section C). 

C. Specifications for Identity and Purity

Specifications for identity and purity of the petitioned food additive should be proposed.8  If published specifications for the food additive are available, for example in the Food Chemicals Codex (FCC), 6th (2008) or current edition,9 then these should be cited and appropriately referenced.  The data provided in this section of a food additive petition should represent a complete compositional analysis of the food additive.  Proposed specifications should include:

  1. A description of the food additive (e.g., physical form, odor, color, and solubility).  For food additives derived from natural sources, the sources themselves should be clearly identified.
  2. Identification tests for the food additive, including the method(s) used or reference(s) for a suitable method(s).
  3. An assay of purity for the additive, including the method used or reference to a suitable method.
  4. Physico-chemical characteristics of the food additive (e.g., ash content, moisture content, melting point, density, refractive index, pH).
  5. Parameters related to the particle size, shape, and surface properties of the food additive, as appropriate, if particle size is important for the identity and functionality of the additive.
  6. Limits for impurities and contaminants.
    1. A limit for lead should be proposed.  In addition, limits for arsenic and heavy metals, such as cadmium and mercury, should be considered when their presence needs to be controlled.
    2. Limits for any known natural toxicants or for microbial contaminants in or on a food additive derived from a natural source should be proposed.
    3. Limits for residual reactants, reaction by-products, and residual solvents should be proposed.

In light of continuing concern over the level of lead in the food supply, special attention should be paid to the proposed specification for lead.  Actual lead levels should be determined and specifications proposed accordingly.  Keep in mind that the proposed specification should be as low as technically feasible taking into account the source and manufacturing process of the food additive, availability of appropriate analytical methodology, and probable human exposure to the food additive.

In order to demonstrate conformance with the proposed specifications, at least five batches of the food additive should be analyzed.  If the analytical method is a common standard test (e.g., FCC or AOAC INTERNATIONAL (AOAC) method), only the reference needs to be provided.  If the method is not common, if a common method is applied to a new food additive, or if a modified standard method is used, a detailed description of the method and validation data for the method should be provided (see Section F for a discussion of analytical data requirements).

D. Stability of the Food Additive

Data demonstrating the stability of the additive should be included, particularly if the additive is sensitive to environmental conditions, such as moisture, air, or temperature, or otherwise has a limited stability.  Stability testing should be conducted under the intended conditions of use of the food additive over its anticipated lifetime.

A description of the stability tests should be straightforward and sufficiently detailed for understanding.  All raw data, including copies of instrument recordings, a data summary, and analytical methods should be provided.

E. Intended Technical Effect and Use

Food additives are used to accomplish a variety of technical effects.  For example, an additive may be classified as an antimicrobial agent, humectant, flavoring agent, surface-active agent, stabilizer or thickener.  These terms, as defined in 21 CFR 170.3(o), describe physical or technical functional effects for which food additives are intentionally added to foods.  The quantity of the additive shall not exceed the amount reasonably required to accomplish its intended technical effect(s) in the food [21 CFR 172.5(a)(1)].

A discussion of the intended use and use level of the additive should include:

  1. The type of food in which the additive will be used. The petitioned uses should be as broad as possible, consistent with the petitioner's burden to provide data demonstrating that all requested uses are safe. However, if the petitioner wishes to limit that burden, the intended restrictions on the uses must be explicit. For example, if the use of the additive is being requested only for certain types of baked goods (e.g., cakes or pies) but not others (such as bread), the types of baked goods should be specified in the petition.
  2. Use level of the additive in each food in which the additive is intended to be used. Maximum and typical use levels expressed as a concentration (by weight), e.g., in milligrams per kilogram or grams per kilogram should be provided.
  3. A clear statement of the intended technical effect(s) of the additive in food. If technical effect of the additive is related to particle size, the statement should explain how size-dependent properties of the additive affect functionality (e.g., solubility, viscosity, stability, antibacterial properties, antioxidant properties).
  4. The fate of the additive in food as consumed, including the identities and amounts of degradation products that will be formed during storage or heating.
  5. Any recommendations, suggestions and directions for use, including specimens of labeling.

Data should be submitted to demonstrate the amount of the additive required to achieve the intended technical effect.  To demonstrate the minimum level required to accomplish the intended technical effect, the functionality of the food additive should be evaluated at several levels above and below the proposed use level (e.g., at levels of ½, 1, and 2 times the intended use level).  Some food additives may have a technologically self-limiting use level; that is, the food additive has a maximum concentration in food above which the food becomes unpalatable, unappealing, or otherwise unfit for human consumption.  In such a case, data should be provided that demonstrate the effect of the additive on the food at several levels above and below the proposed self-limiting level.

The depth and degree of the data required to demonstrate the intended technical effect can vary, depending upon the additive.  For example, data can range from a simple organoleptic evaluation to a complex chemical analysis.  Regardless of the degree of sophistication of the method, the experiments should be carefully designed, taking into account the need for controls.  For relatively new substances or novel technical effects, samples of food, with or without the added substance, might be requested for analysis; however, the petitioner should not provide such samples unless expressly requested by FDA during the petition evaluation.

F. Methodology for Analysis of the Additive in Food

If assurance of safe use of an additive depends on a limitation imposed on the amount of a substance (the additive, its associated impurities, or its degradation products) that a food can contain, a method that can quantify the substance in food for the purpose of enforcing this limit should be provided.  Quantifying the levels of a substance in food requires a practical analytical method that can be readily performed by appropriately trained personnel in a properly equipped laboratory.  The method must be specific, accurate, precise, and reliable.  However, the method must not be so sophisticated or complicated that it can be carried out only in laboratories with highly specialized equipment or by specially trained personnel.  If analytical testing has been contracted out, the raw data from the contract laboratory should be provided in the petition, as well as the contract laboratory methods and relating validation data.  If the analytical method will be incorporated by reference in the regulation, 1 CFR 51.9(b)(2) states that the regulation must identify the title, date, edition, author, publisher, and identification number of the analytical method incorporated by reference. 

The following is a suggested general format for an acceptable analytical method.

  1. Introduction.  A brief summary of the method, including its principle, scope and limitations should be provided.  This section should describe the types of food to which the method may be applied, the substance(s) that can be detected by the method, and the types of substances that would interfere with the method.
  2. Materials.  Except for common laboratory items, a detailed description of the reagents (including grades of reagents and protocols for preparation of any reagents), equipment, instrumentation (including model numbers), computer software, etc. should be provided.  It should be noted where "similar" or "equivalent" materials or equipment might be suitable.
  3. Sample Preparation.  A complete, clear, concise description of the preparation of food samples that contain the additive, or other analyte of interest in a step-by-step format should be provided.  Samples from five different production lots or batches should be prepared for analysis in triplicate.  Blanks and control samples should also be analyzed in triplicate.

    FDA may request samples of the additive to verify the method, but these samples should be furnished only upon request.  If requested, FDA will provide instructions as to the types and amounts of samples that should be provided for such analyses.
  4. Standard or Reference Solutions.  Standard solutions, consisting of the additive, or any other analyte of interest, at five different concentrations that bracket the expected concentration of the substance in the food extract resulting from the sample preparation, should be prepared and analyzed in triplicate.  For example, if the concentration of the additive in the food extract is 1.0 microgram/ml, standard solutions should be prepared at 0.25, 0.5, 1.0, 1.5, and 2.0 microgram/ml.  The data obtained from the analysis of these solutions should be used to construct a standard or calibration curve.
  5. Equipment Calibration and Set-up.  Instructions for calibrating equipment, introducing the sample, and performing the analysis in step-by-step detail, including the experimental set-up and system operating parameters, should be provided.  Any precautions and special instructions necessary to carry out the analysis successfully should be noted.  If applicable, trouble-shooting techniques should be provided.
  6. Limits of Detection and Quantitation. 10 The limit of detection is the lowest concentration of analyte that the analytical method can reliably detect.  It is preferable that the limit of detection be determined from triplicate analyses of five blank samples (e.g., food matrix without the added substance).  The blank signal (i.e., the analyte response for the blank sample or the width of the baseline close to the actual or expected analyte peak) should be measured, and the average signal and standard deviation for the blank should be calculated.  The limit of detection is three standard deviations above the average blank signal.  For cases in which it is not feasible to determine the limit of detection using blank samples, the limit of detection should be determined from the peak-to-peak noise measured on the baseline close to the actual or expected analyte signal.

    The region for quantitation of the analyte should be above the limit of detection.  The limit of quantitation is ten standard deviations above the average blank signal.
  7. Validation.  The usual validation procedure consists of spiking and recovery studies.  Samples used for these studies should be fortified with known concentrations of the analyte, similar to the concentration that will be found in food containing the additive.  The percent recovery is defined as: {[a - b] / c} x 100%, where "a" is the measured level of the analyte analytically determined in the fortified sample, "b" is the "background" level (i.e., the measured level determined in the unfortified sample), and "c" is the amount of analyte added to the fortified sample.

    Spiking and recovery experiments should be performed using samples consisting of food formulated with the additive.  Unfortified ("background") samples should consist of the formulated food containing the additive.  Fortified ("spiked") samples should be identical to the "background" samples, but are fortified ("spiked") with a known amount of analyte.  Typically, the samples are "spiked" at levels of one-half of, equal to, and twice the typical additive use level or analyte concentration (or limit of detection, if applicable).  The range of spiking levels should be broad enough to encompass or bracket the total range of use levels, as well as any regulatory tolerances.  All samples should be analyzed in triplicate.  Results of spiking experiments should demonstrate between 80 and 110% recovery for analyte concentrations above 0.1 mg/kg, and between 60 and 110% recovery for concentrations below 0.1 mg/kg.

    In some cases, it might be necessary to confirm the identity of the additive being analyzed by an independent analytical technique.  FDA would request this information in those cases.
  8. Precision and Statistical Treatment of Data.  A discussion of the statistical treatment of the data is beyond the scope of this document; therefore, appropriate texts should be consulted in this regard.  Nevertheless, a petition should include a discussion of the statistical method(s) employed for analyzing the data, including special techniques or other pertinent information.  Usually, good laboratory precision is indicated by a relative standard deviation of less than 10% for analytical values above 0.1 mg/kg and less than 20% for analytical values below 0.1 mg/kg.  When analytical values are above the mg/kg range, precision is generally expected to be better than 10%.
  9. Reporting of Data.  A balanced analytical report should be submitted; both favorable and unfavorable results should be included.  Raw data sufficient for an independent evaluation of the data should be included; raw data may include copies of instrument recordings, notebook pages, computer printouts, etc.  In addition, sample calculations for the construction of calibration curves and for the determination of the amount of analyte in the food samples based upon the raw analytical data should be provided.

G. Intake Estimate

As part of the petition process for regulation of a food additive, the consumer intake of the additive, and its by-products, resulting from ingestion of food containing the additive, must be estimated.  This estimate, known as the estimated daily intake (EDI), is intended to represent chronic intake (i.e., average daily intake over a lifetime) of the food additive.  The EDI is typically calculated for the "average" consumer and the "high" consumer.  The Agency considers the "high" consumer as one belonging to that subgroup of the population that consumes, on a regular basis, greater quantities of a particular food than the "average" consumer.  For purposes of the estimate, the "high" consumer subpopulation is generally represented by the consumers of a given food at the 90th percentile.

OFAS will calculate an EDI for the food additive based upon the following information provided by the petitioner:

  1. The specific foods in which the additive is to be used.
  2. The typical and maximum use levels of the additive in each food.
  3. The identity of subpopulations that might be particularly affected by the use of the additive (e.g., an additive that will be used in infant formula or low-calorie foods).
  4. Any anticipated increase in consumption from its petitioned use(s), if the petition involves a new use or an increased level of use of a food additive that is covered by an existing regulation.
  5. Any anticipated increase in consumption from its petitioned use(s), if the food additive is also a naturally occurring material.  The concentration of the additive occurring naturally in food(s) and an estimate of the level of consumption of the food(s) should be provided.

Typically, OFAS makes some basic assumptions in calculating an intake estimate for a food additive.  These assumptions generally lead to a conservative estimate of the intake. First, OFAS assumes that the additive is used at the maximum petitioned level.  Second, OFAS assumes that the additive is used in all foods intended to be formulated with the additive.

However, depending on the data available and the intended use of the food additive, OFAS may consider alternative approaches in calculating an EDI, e.g., use of the typical use level of the additive, or consideration of market share of the food formulated with the additive.  If the petitioner wishes to use an alternative approach in calculating an EDI, the basis for applying this approach must be fully described, with supporting documentation, in the petition.

A more thorough discussion of OFAS' approaches to estimating consumer intake may be found elsewhere.11

Although OFAS will determine the EDI for a food additive, petitioners are encouraged to provide their own EDI calculation in the petition.  If the petitioner chooses to calculate an EDI, the petitioner should consult the above-referenced document11 for information on food consumption data.  The petitioner should provide, at minimum, a mean EDI (to represent the "average" consumer) and the EDI at the 90th percentile (to represent the "high" consumer), assuming a maximum use level of the food additive in all foods intended to be formulated with the additive.  Alternative approaches to calculating the EDI may also be appropriate.  However, the EDI must be based on reasonable consumption scenarios that would be permitted under the petitioned regulation; it should not be based solely on the petitioner's current marketing plans.

In certain cases, the food consumption and use level information necessary for the estimation of intake is inadequate or unavailable.  Difficulties can arise in estimating intake when current eating habits cannot be reliably extrapolated to predict the probable intake of the new substance.  In these cases, new approaches to the intake estimate might need to be derived, for example, in the area of food additives that could become macro-ingredients (e.g., fat replacements) in the diet.  The petitioner may wish to review other guidance11 and consult with OFAS in agreeing to a suitable approach. 

IV. Additional Information and Requirements 

These recommendations do not address administrative, toxicological, microbiological, nutritional, environmental assessment, or labeling requirements that a petitioner should satisfy. Information on these or other requirements, as well as specific inquiries regarding food additive petitions, can be obtained by contacting the Office of Food Additive Safety, 5001 Campus Drive, College Park, MD  20740-3835, or at Food and Cosmetic Guidance Documents.

1. This guidance has been prepared by the Division of Petition Review in the Office of Food Additive Safety Center for Food Safety and Applied Nutrition (CFSAN) at the U.S. Food and Drug Administration.

2. A class of food additives that does not neatly fit into either the direct or indirect food additive categories, the so-called secondary direct food additives, are codified in 21 CFR Part 173.  These are food additives whose functionality is required during the manufacture or processing of food and are ordinarily not expected to be present in the final product; although residuals might carry over to the final product, these residuals are not expected to exhibit any technical effect in food.  Examples of secondary direct additives include enzyme immobilizing agents, ion exchange resins, and other processing aids.  The chemical and technological data needs for evaluation of petitions for secondary direct additives vary according to the proposed use of the additive.  Information regarding submission of data for secondary direct additives may be requested from the Office of Food Additive Safety, 5001 Campus Drive, College Park, MD  20740-3835.

3. Articles used in contact with food and substances used to manufacture them, including processing equipment, are indirect food additives (food-contact substances (FCSs)) if they or their components inadvertently become a component of the food through direct contact.  Indirect additives are codified in 21 CFR Parts 174-178.  Section 309 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) amended section 409 of the Act to establish a food contact notification (FCN) as the primary means by which FDA evaluates food additives that are FCSs.  More information on the FCN process can be found at the following websites:  Preparation of Food Contact Notifications: Administrative and Preparation of Food Contact Notifications and Food Additive Petitions for Food Contact Substances: Chemistry Recommendations.  The development of the notification program does not preclude submission of an indirect food additive petition.  Situations in which a food additive petition is required for a FCS are outlined in OFAS's administrative guidance for the preparation of food contact notifications, which can be found at: Preparation of Food Contact Notifications: Administrative.

4. See 21 CFR Part 179.

5. The CFR contains two sections of regulations of substances that are GRAS.  The first section, 21 CFR Part 182, lists substances that were in common use prior to the 1958 amendment to the Federal Food, Drug, and Cosmetic Act.  The second section, 21 CFR Part 184, contains those substances that have been affirmed as GRAS by the Agency since the Presidential Directive of 1969.  This Directive required the Agency to initiate a safety review of the status of all ingredients that were on the GRAS list, with the intention of affirming their use as GRAS, determining that they were subject to prior sanction, or concluding that they should be regulated as food additives.

Since 1997, FDA has had in place a GRAS Notification program (Proposed rule: 62 FR 18937), which is a voluntary process that allows a notifier to inform FDA of its determination that a particular use of a substance is GRAS.  The program permits notifiers to submit a summary of their basis for the GRAS determination and, at the same time, gives FDA the opportunity to raise questions or concerns regarding the basis for that determination.  Additional information on the GRAS notification program can be found at:GRAS Notification Program.  The agency is developing the final rule for Substances Generally Recognized as Safe (Docket Number 97N-0103).

6. Guidance for the submission of chemical and technological data on color additives for food, drugs, or cosmetics. 

7. Guidance for requesting information and/or records from FDA through the Freedom of Information Act (FOIA) can be found at A Handbook for Requesting Information and Records from FDA.

8. Specifications serve only as minimal criteria for establishing that a substance intended for use in food is "food-grade."  For a food additive to be considered food-grade, it shall also have been manufactured, packaged, stored, and transported under sanitary conditions that preclude, for example, contamination, formation of undesirable degradation products, and mislabeling.  Controls or systems to avoid such problems should be established by manufacturers, processors, packers, and distributors throughout their operation.  These practices, combined with adherence to the specifications for identity and purity constitute "good manufacturing practice" or GMP.  Further elaboration on GMP can be found in the Food Chemicals Codex (FCC).

9. Copies of the FCC are available from the United States Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, MD 20852; http://www.usp.org; 1-800-227-8772.

10. Guidelines for Data Acquisition and Data Quality Evaluation in Environmental Chemistry (1980) Anal. Chem. 52:2242-2249 and (1983) Anal. Chem. 55:2210-2218.

11. A discussion of some of the approaches FDA could possibly use to estimate intake of a food additive can be found in the document titled "Estimating Dietary Intake of Substances in Food".  

Related Information

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