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Hazard Analysis and Risk-Based 

Preventive Controls for Human Food: 

Draft Guidance for Industry1

This draft guidance, when finalized, will represent the current thinking of the Food and Drug 

Administration (FDA or we) on this topic. It does not establish any rights for any person and is 

not binding on FDA or the public. You can use an alternative approach if it satisfies the 

requirements of the applicable statutes and regulations. To discuss an alternative approach, 

contact FDA’s Technical Assistance Network by submitting your question at 

https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-technical-assistancenetwork-tan. 

Chapter 11: Food Allergen Program

Table of Contents

11.1. Purpose of This Chapter

11.2 Terms Used in This Chapter

11.2.1 Definitions Established in 21 CFR 117.3

11.2.2 Other Terms That FDA Uses in This Chapter

11.2.3 Abbreviations Used in This Chapter

11.3 Understand the Hazard Requiring a Preventive Control

11.4 Considerations If You Establish and Implement a Food Allergen 

Program

11.4.1 Preventive Controls for Allergen Cross-Contact Enhance the CGMP Control 

Measures in Your Food Allergen Program

11.4.2 Foods That Contain a Major Food Allergen Are Subject to the Allergen 

Labeling Requirements of the FD&C Act

11.4.3 Policy Statements and Other Guidance Regarding Allergen Labeling

11.5 Develop a Strategy for Preventive Control Management Components

11.5.1 Overview of Preventive Control Management Components

1 This guidance has been prepared by the Office of Food Safety in the Center for Food Safety and 

Applied Nutrition at the U.S. Food and Drug Administration.
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11.5.2 Monitoring and Verification

11.5.2.1 Requirements for monitoring

11.5.2.2 Requirements for verification

11.5.2.3 Flexibility in complying with the requirements for monitoring and 

verification for allergen cross-contact controls and label controls

11.5.3 Corrective Actions and Corrections

11.5.4 Applying Preventive Control Management Components to Supply-Chain 

Controls

11.5.5 Reanalysis

11.5.6 Records Documenting the Preventive Control Management Components

11.6 Allergen Cross-contact Controls

11.6.1 Allergen Cleaning Procedures

11.6.1.1 Monitoring and Verification for Allergen Cleaning Procedures

11.6.1.2 Corrective Actions and Corrections for Allergen Cleaning Procedures

11.6.1.3 Reanalysis of Your Allergen Cleaning Procedures

11.6.1.4 Records Documenting Allergen Cleaning Procedures and Applicable 

Preventive Control Management Components

11.6.2 Allergen Ingredient Procedures

11.7 Label Controls

11.7.1 Preventive Controls for the Content of the Product Label and for Managing 

Labels

11.7.1.1 Label controls for the content of the product label

11.7.1.2 Label controls for managing product labels/packages

11.7.2 Monitoring and Verification for Label Controls

11.7.2.1 What to monitor or verify for a label control

11.7.2.2 How to monitor or verify a label control

11.7.2.3 How often to monitor or verify a label control

11.7.2.4 Who monitors or verifies a label control

11.7.3 Corrective Actions/Corrections for Label Controls

11.7.4 Reanalysis for Label Controls

11.7.5 Records Documenting the Label Controls and Applicable Preventive 

Control Management Components

11.8 Supply-Chain Program

11.8.1 Regulatory Framework for the Supply-Chain Program
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11.8.2 When to Establish and Implement a Supply-chain Program as a Preventive 

Control for a Food Allergen Hazard

11.8.3 Supplier Approval and Supplier Verification Activities in a Supply-Chain 

Program for the Control of Food Allergen Hazards

11.8.3.1 Evaluating whether a potential supplier provides allergen advisory 

statements for raw materials or other ingredients that you would receive 

from the supplier before approving the supplier

11.8.3.2 Determining the appropriate supplier approval and verification activities

11.8.3.3 Conducting an audit of a supplier when the hazard requiring a supplychain applied control is a food allergen hazard

11.8.4 Receiving a Raw Material or Other Ingredient From a Supplier That 

Provides Allergen Advisory Statements

11.8.5 Corrective Actions and Corrections in the Event of Supplier Nonconformance

11.8.6 Reanalysis in the Event of Ongoing Supplier Nonconformance

11.8.7 Records Documenting the Supply-Chain Program

11.8.8 Review of Records for the Supply-Chain Program

11.9 Allergen Advisory Statements

11.9.1 How the 1996 Food Allergen Notice Applies to CGMP Measures and PCHF 

Requirements

11.9.2 Justification by Your Preventive Controls Qualified Individual That an 

Allergen Advisory Statement Is Necessary and Appropriate

11.9.3 Suppliers That Use Allergen Advisory Statements

11.9.4 Reanalysis of Your Determination That Allergen Advisory Statements Are 

Appropriate If You Experience Ongoing Problems with Your Allergen CrossContact Controls or Your Supply-Chain Program

11.10 Training

11.11 Examples Used in this Chapter

11.12 Example of a Food Allergen Program Established and Implemented 

by Dessert Manufacturer A for the Production of Ice Cream and Other 

Frozen Dessert Products

11.12.1 Dessert Manufacturer A’s Products and Hazard Analysis

11.12.2 Dessert Manufacturer A’s Food Allergen Program

11.12.2.1 Dessert Manufacturer A’s CGMP measures in its food allergen program

11.12.2.2 Dessert Manufacturer A’s food allergen controls
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11.12.2.3 Dessert Manufacturer A’s assessment of supply-chain controls related to 

food allergens

11.12.3 Dessert Manufacturer A’s Allergen Cross-Contact Control

11.12.3.1 Dessert Manufacturer A’s allergen cleaning procedures

11.12.3.2 Dessert Manufacturer A’s monitoring/verification of allergen cleaning 

procedures

11.12.3.3 Dessert Manufacturer A’s corrective actions/corrections for allergen 

cleaning procedures

11.12.3.4 Dessert Manufacturer A’s records for allergen cleaning procedures and 

associated preventive control management components

11.12.4 Dessert Manufacturer A’s Label Controls

11.12.4.1 Dessert Manufacturer A’s label content controls and label management 

controls

11.12.4.2 Dessert Manufacturer A’s monitoring/verification of label controls

11.12.4.3 Dessert Manufacturer A’s corrective actions/corrections for label controls

11.12.4.4 Dessert Manufacturer A’s records for label controls and associated 

preventive control management components

11.12.5 Summary of Dessert Manufacturer A’s Food Allergen Program

11.13 Example of Food Allergen Program Established and Implemented by 

Bakery B for the Production of a Variety of Cookie Products

11.13.1 Bakery B’s Products and Hazard Analysis

11.13.2 Bakery B’s Food Allergen Program

11.13.2.1 Bakery B’s CGMP measures in its food allergen program

11.13.2.2 Bakery B’s food allergen controls

11.13.2.3 Bakery B’s assessment of supply-chain controls related to food allergens

11.13.3 Bakery B’s Allergen Cross-contact Controls

11.13.3.1 Bakery B’s allergen cross-contact controls on utensils, tools, apparel, and 

movement of personnel

11.13.3.2 Bakery B’s monitoring/verification of allergen cross-contact controls

11.13.3.3 Bakery B’s corrective actions/corrections for allergen cross-contact 

controls

11.13.3.4 Bakery B’s records for allergen cross-contact controls and associated 

preventive control management components

11.13.4 Bakery B’s Label Controls

11.13.4.1 Bakery B’s label content controls and label management controls
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11.13.4.2 Bakery B’s monitoring/verification of label controls

11.13.4.3 Bakery B’s corrective actions/corrections for label controls

11.13.4.4 Bakery B’s records for label controls and associated preventive control 

management components

11.13.5 Bakery B’s Supply-chain Controls

11.13.5.1 The ingredient with a food allergen hazard that requires a supply-chainapplied control

11.13.5.2 The two vegan caramel chip processors that Bakery B evaluates as 

potential suppliers

11.13.5.3 Bakery B’s supplier approval and verification activities

11.13.5.4 Bakery B’s corrective actions/corrections in the event of supplier nonconformance

11.13.5.5 Bakery B’s records documenting its supply-chain controls

11.13.6 Summary of Bakery B’s Food Allergen Program

11.14 References

11.15 Resources

Appendix 11-1 CGMP Measures to Prevent Allergen Cross-Contact

11-1.A CGMP Measures Are Part of Your Food Allergen Program

11-1.B CGMP Measures to Prevent Allergen Cross-Contact by Personnel

11-1.C CGMP Measures for the Design and Construction of the Plant to Prevent 

Allergen Cross-Contact

11-1.D CGMP Measures for Sanitary Operations to Prevent Allergen CrossContact

11-1.E CGMP Measures on Equipment and Utensils to Prevent Allergen CrossContact

11-1.F CGMP Measures for Raw Materials and Other Ingredients, and for 

Manufacturing Operations, to Prevent Allergen Cross-Contact

11-1.F.1 CGMP measures for raw materials and other ingredients to prevent 

allergen cross-contact

11-1.F.2 CGMP measures for manufacturing operations to prevent allergen crosscontact

11-1.G CGMP Measures for Warehousing and Distribution to Prevent Allergen 

Cross-contact

Appendix 11-2 Summary of Dessert Manufacturer A’s Food Allergen 

Controls and Associated Preventive Control Management 

Components
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FORM 2-D (Modified) Allergen Cleaning Procedures

FORM 2-E (Modified) FOOD ALLERGEN INGREDIENT ANALYSIS

FORM 2-F (Modified) FOOD ALLERGEN LABEL VERIFICATION LIST

FORM 2-G (Modified) PRODUCTION LINE FOOD ALLERGEN ASSESSMENT

Appendix 11-3 Summary of Bakery B’s Food Allergen Controls and 

Associated Preventive Control Management Components

FORM 2-E (Modified) FOOD ALLERGEN INGREDIENT ANALYSIS

FORM 2-F (Modified) FOOD ALLERGEN LABEL VERIFICATION LIST

FORM 2-G (Modified) PRODUCTION LINE FOOD ALLERGEN ASSESSMENT

11.1. Purpose of this Chapter

The purpose of this chapter is to explain how to establish and implement a food allergen

program. Part 117 defines “food allergen” as a major food allergen as defined in section 201(qq) 

of the FD&C Act (21 CFR 117.3). Section 201(qq) of the FD&C Act defines the term ‘‘major food 

allergen,’’ in part, to mean any of the following: Milk, egg, fish (e.g., bass, flounder, or cod), 

Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or 

walnuts), wheat, peanuts, soybeans, and sesame2 or a food ingredient that contains protein 

derived from one of these foods, with certain exceptions regarding highly refined oils.

A food allergen program could include, as appropriate to the facility and its food products: 

• CGMP measures that you take to comply with the requirements of part 117, subpart B, to 

prevent allergen cross-contact3 due to personnel, design and construction of the plant, 

sanitary operations, equipment and utensils, raw materials and other ingredients,

manufacturing operations, and warehousing and distribution. Your hazard analysis should 

consider how your CGMP measures prevent allergen cross-contact, and the preventive 

controls that you establish and implement to address a food allergen hazard should 

complement and enhance your CGMP measures for preventing allergen cross-contact. 

2 In 2004, the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) amended the 

FD&C Act to provide FDA with additional, specific authority regarding the labeling of a food (other than a 

raw agricultural commodity) that bears or contains a “major food allergen.” Under section 403(w) of the 

FD&C Act (21 U.S.C. 343(w)), a food is misbranded if it contains a major food allergen and fails to declare 

that major food allergen on its label in the manner specified using the major food allergen’s common or 

usual name, including the name of the food source from which the major food allergen is derived. Section 

201(qq)(1) of the FD&C Act (21 U.S.C. 321(qq)(1)) defined a “major food allergen,” in part, as any of the 

following: milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans. The specified 

labeling requirements became effective on January 1, 2006, for packaged foods. In April 2021, the Food 

Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act) amended section 201(qq) 

of the FD&C Act to add sesame to the definition of “major food allergen.” This amendment applies to “any 

food that is introduced or delivered for introduction into interstate commerce on or after January 1, 2023”

(Public Law 117-11).

3 Part 117 defines “allergen cross-contact” as the unintentional incorporation of a food allergen into a 

food. (See 21 CFR 117.3.)
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• Food allergen controls to provide assurances that any food allergen hazards requiring a 

preventive control will be significantly minimized or prevented. (See 21 CFR 117.135(a) and 

(c)(2).) Food allergen controls include procedures, processes, and practices that are:

o Allergen cross-contact controls – i.e., procedures, practices, and processes employed 

for ensuring protection of food from allergen cross-contact, including during storage, 

handling, and use (21 CFR 117.135(c)(2)(i)); and 

o Label controls – i.e., procedures, practices, and processes employed for labeling the 

finished food, including ensuring that the finished food is not misbranded under section 

403(w) of the FD&C Act (21 U.S.C. 343(w)). (21 CFR 117.135(c)(2)(ii).)

• A supply-chain program as required by part 117, subpart G for those raw materials and 

other ingredients for which a manufacturing/processing facility has identified a food allergen 

hazard that is controlled before its receipt. (See 21 CFR 117.405(a)(1).) See Chapter 15 for 

comprehensive guidance on how to comply with the requirements of part 117, subpart G for 

all hazards, not just food allergen hazards.

In this chapter, we provide multiple, detailed recommendations for each of these aspects of a 

food allergen program. Our purpose is to provide as many examples as possible so that you can 

develop your own food allergen program as appropriate to your operations, not to imply that a 

food allergen program should have all the CGMP measures, preventive controls (including 

supply-chain controls), monitoring/verification activities, corrective action procedures, and 

records that we describe for illustrative purposes. 

For background and details about food allergen hazards, see section 3.4.2.1 of Chapter 3. For a 

preliminary discussion of food allergen controls, see section 4.5 of Chapter 4. For an overview 

of the application of preventive control management components to food allergen controls, see 

section 5.3.3 of Chapter 5. For the definitions of terms used in this chapter, see section III in the 

Introduction of this guidance and section 11.3 in this chapter.

This chapter does not address substances that are associated with food allergy but are not 

major food allergens defined in section 201(qq) of the FD&C Act. However, you may find the 

recommendations in this chapter for food allergen controls to be useful for such substances if 

appropriate for your food and facility. This document also does not address substances (e.g., 

sulfites and yellow No. 5) that are associated with food intolerance or substances (e.g., gluten) 

that are associated with food-related disease (e.g., celiac disease) as discussed in section 

3.4.2.2 of Chapter 3 of this guidance. However, you may find the recommendations in this 

chapter for label controls for food allergens to be a useful tool for developing your strategy for 

complying with any regulatory requirements for labeling such substances, even though the 

labeling requirements for such substances are different from the labeling requirements for the 

major food allergens.

4

In a 1996 notice to manufacturers entitled “Label Declaration of Allergenic Substances in Foods” 

(the 1996 food allergen notice) (see Table 11-8), we advised the food industry that we were 

aware that some manufacturers are voluntarily labeling their products with statements such as 

4 For example, sulfiting agents permitted in foods must be listed on the ingredient label, unless they are 

added to food as an “incidental substance” (i.e., because they have no technical effect in the finished food 

and are present at less than 10 parts per million (ppm)). (See 21 CFR 101.100(a)(4).) As a second 

example, our regulation for the color additive Yellow No. 5 states that any food for human use that 

contains Yellow No. 5 must specifically declare the presence of the color additive by listing it as an 

ingredient. (See 21 CFR 74.705(d)(2).) 
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"may contain (insert name of allergenic ingredient)." In the 1996 food allergen notice and in our 

allergen labeling guidance (see Table 11-7), we advised that labeling such as “may contain 

[allergen]” is not a substitute for, and should not be used in lieu of, adherence to CGMPs. Our 

allergen labeling guidance also advises that labeling such as “may contain [allergen]” is not a 

substitute for adherence to food allergen preventive controls and that any such statement must 

be truthful and not misleading. In the 1996 food allergen notice, we also urged manufacturers to 

“take all steps necessary to eliminate cross-contamination and to ensure the absence of the 

identified food.” Consistent with the 1996 food allergen notice and our allergen labeling 

guidance, in section 11.9 of this chapter we advise that:

• You should not use allergen advisory statements (formerly called allergen precautionary 

labeling) in lieu of adherence to CGMPs or in lieu of the requirements for allergen crosscontact controls;

• If you use allergen advisory statements, they must be truthful and not misleading;

• If you use allergen advisory statements, your preventive controls qualified individual (PCQI)

should provide a written justification, in your food safety plan, for why allergen cross-contact 

controls cannot ensure protection of food from allergen cross-contact;

• Your supplier approval and verification activities should include an evaluation of whether a 

potential supplier provides allergen advisory statements for raw materials and other 

ingredients that you would receive from the potential supplier. When a potential supplier 

would provide an allergen advisory statement on the applicable raw materials or other 

ingredients, you should discuss the reasons for the allergen advisory statements with the 

potential supplier. You should approve such suppliers only if you determine, through your 

supplier approval and verification activities, that such statements are not being used in lieu 

of adherence to CGMPs or in lieu of adherence to the requirements for allergen crosscontact controls; and

• Reanalysis of your determination regarding using allergen advisory statements is 

appropriate if you experience ongoing problems with your allergen cross-contact controls or 

your supply-chain controls. 

This chapter does not broadly discuss other issues associated with allergen advisory

statements. See the discussion of labeling policy statements and other guidance regarding 

allergen labeling in section 11.4.3 and our web page providing guidance documents and 

regulatory information regarding food allergens (see Table 11-8) for the most current policy 

statements and other guidance relevant to allergen advisory statements. You should periodically 

check that web page for updates to these policy statements and other guidance.

11.2 Terms Used in This Chapter

11.2.1 Definitions Established in 21 CFR 117.3

Section III.A in the Introduction of this guidance includes a glossary of terms that are used in 

this guidance and are defined in 21 CFR 117.3. At this time, that glossary does not include all 

terms that are used in this chapter. See Table 11-1 for additional terms that are defined in 21 

CFR 117.3. We intend to include these terms in the glossary in section III.A in the Introduction 

of this guidance when we update the Introduction. When we do so, we intend to delete Table 

11-1 from this chapter, because it would be duplicative.
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Table 11-1 Applicable Terms Defined in Part 117 (See 21 CFR 117.3.)

Term What the Term Means

Allergen cross-contact The unintentional incorporation of a food allergen into a food.

Audit The systematic, independent, and documented examination (through observation, 

investigation, records review, discussions with employees of the audited entity, and, 

as appropriate, sampling and laboratory analysis) to assess a supplier’s food safety 

processes and procedures.

Food allergen A major food allergen as defined in section 201(qq) of the FD&C Act.

Lot The food produced during a period of time and identified by an establishment’s 

specific code.

Manufacturing/ 

processing

Making food from one or more ingredients, or synthesizing, preparing, treating, 

modifying or manipulating food, including food crops or ingredients. Examples of 

manufacturing/processing activities include: Baking, boiling, bottling, canning, 

cooking, cooling, cutting, distilling, drying/dehydrating raw agricultural commodities to 

create a distinct commodity (such as drying/dehydrating grapes to produce raisins), 

evaporating, eviscerating, extracting juice, formulating, freezing, grinding, 

homogenizing, irradiating, labeling, milling, mixing, packaging (including modified 

atmosphere packaging), pasteurizing, peeling, rendering, treating to manipulate 

ripening, trimming, washing, or waxing. For farms and farm mixed-type facilities, 

manufacturing/processing does not include activities that are part of harvesting, 

packing, or holding.

Qualified auditor A person who is a qualified individual as defined in part 117 and has technical 

expertise obtained through education, training, or experience (or a combination 

thereof) necessary to perform the auditing function as required by § 117.180(c)(2). 

Examples of potential qualified auditors include: (1) A government employee, 

including a foreign government employee; and (2) An audit agent of a certification 

body that is accredited in accordance with regulations in 21 CFR part 1, subpart M 

(Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and 

To Issue Certifications).

Receiving facility A facility that is subject to subparts C and G of part 117 and that 

manufactures/processes a raw material or other ingredient that it receives from a 

supplier.

Rework Clean, unadulterated food that has been removed from processing for reasons other 

than insanitary conditions or that has been successfully reconditioned by 

reprocessing and that is suitable for use as food.

Supplier The establishment that manufactures/processes the food, raises the animal, or grows 

the food that is provided to a receiving facility without further 

manufacturing/processing by another establishment, except for further 

manufacturing/processing that consists solely of the addition of labeling or similar 

activity of a de minimis nature.

Supply-chain-applied 

control

A preventive control for a hazard in a raw material or other ingredient when the 

hazard in the raw material or other ingredient is controlled before its receipt.

Written procedures for 

receiving raw materials 

and other ingredients

Written procedures to ensure that raw materials and other ingredients are received 

only from suppliers approved by the receiving facility (or, when necessary and 

appropriate, on a temporary basis from unapproved suppliers whose raw materials or 

other ingredients are subjected to adequate verification activities before acceptance 

for use).

11.2.2 Other Terms That FDA Uses in This Chapter

Section III.B in the Introduction of this guidance includes a glossary of terms that are used in 

this guidance but are not defined in 21 CFR 117.3. At this time, that glossary does not include 
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all terms that are used in this chapter. See Table 11-2 for additional terms that we use in this 

chapter. We intend to include these terms in the glossary in the Introduction of this guidance 

when we update the Introduction. When we do so, we will delete Table 11-2 from this chapter.

Table 11-2 Terms Used in This Chapter

Term What the Term Means

Allergen cleaning 

procedure

Procedures, practices, and processes for cleaning food-contact surfaces of 

equipment and utensils that are used for foods with different food allergen 

profiles 

Allergen cross-contact 

control

Procedures, practices, and processes employed for ensuring protection of 

food from allergen cross-contact, including during storage, handling, and 

use

Allergenic component A food allergen (i.e., a major food allergen as defined in section 201(qq) of 

the FD&C Act) that is a component of an ingredient (e.g., the food allergen 

“milk” in a spice blend)

Allergenic ingredient A food allergen (i.e., a major food allergen as defined in section 201(qq) of 

the FD&C Act) that is an ingredient of another food product (e.g., the food 

allergen “peanuts” added to cookies)

Allergen labeling guidance Questions and Answers Regarding Food Allergens, Including the Food 

Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic 

Act (Edition 5): Guidance for Industry

Approved supplier A supplier that has met the criteria of the receiving facility’s supply chain 

program, is controlling the identified hazard, and has been approved by the 

receiving facility

Certificate of analysis 

(COA) 

A document, provided by the supplier of a food prior to or upon receipt of the 

food, that documents the analysis of certain characteristics and attributes of 

the food

Changeover Procedures used to prepare the processing line when different products are 

produced on the same processing line

Draft allergen labeling 

guidance5

Questions and Answers Regarding Food Allergens, Including the Food 

Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic 

Act (Edition 5): Guidance for Industry (Draft Guidance)

Exception record A record that you establish only when there is loss of control

Food allergen label 

specification

All features of the product label that you will use to ensure that the finished 

food will not be misbranded under section 403(w) of the FD&C Act. 

Examples of such features are product name; the approach to naming the 

food source of all allergenic ingredients (and allergenic components of 

ingredients) (e.g., within the ingredient statement6 or in a separate 

“Contains” statement); and any color coding or other distinctive features that 

you use to help production personnel select the correct label. 

Food allergen profile The food allergen sources present or absent in a food 

Label7 A display of written, printed, or graphic matter upon the immediate container 

of a food article. (See the definition of “label” in section 201(k) of the FD&C 

Act ((21 U.S.C. 321(k))

5 The draft guidance, when finalized, will explain FDA’s current thinking on a number of issues related to 

the labeling of food allergens, including requirements in both FALCPA and the FASTER Act.

6 See 21 CFR 101.4 Food; designation of ingredients.

7 Note that the definition of “label” in section 201(k) of the FD&C Act specifies that a requirement that any 

word, statement, or other information appear on the label shall not be considered to be complied with 

unless such word, statement, or other information also appears on the outside container or wrapper, if 

any there be, of the retail package of such article, or is easily legible through the outside container or 

wrapper. 
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Term What the Term Means

Label control Procedures, practices, and processes employed for labeling the finished 

food, including ensuring that the finished food is not misbranded under 

section 403(w) of the FD&C Act

SAHCODH (Serious 

adverse health 

consequences or death to 

humans) hazard 

A hazard for which there is a reasonable probability that exposure to the 

hazard will result in serious adverse health consequences or death to 

humans.

Third-party audit An audit conducted by a qualified auditor that is not an employee of either 

the receiving facility or the supplier.

Unintended allergen 

presence8

The presence of an allergen due to allergen cross-contact

Visibly clean Without visibly detectable material such as food residue, film, or protein 

sheen

Work-in-process (WIP) Partially finished products that are in between different production stages 

(e.g., batched or pre-processed ingredients that are transferred to totes and 

held until moved to another processing line to be incorporated into another 

product).

11.2.3 Abbreviations Used in This Chapter

Section IV in the Introduction of this guidance includes a list of abbreviations that are used in 

this guidance. At this time, that list of abbreviations does not include all abbreviations that are 

used in this chapter. See Table 11-3 for additional abbreviations that are used in this chapter. 

We intend to include these abbreviations in section IV in the Introduction of this guidance when 

we update the Introduction. When we do so, we will delete Table 11-3 from this chapter. For 

your convenience, Table 11-3 includes some abbreviations, already included in section IV of the 

Introduction of this guidance, that are commonly used in this chapter. 

Table 11-3 Common Abbreviations Used in This Chapter

Abbreviation What It Means

CIP Clean in place

CFR Code of Federal Regulations

CGMP Current good manufacturing practice

FALCPA Food Allergen Labeling and Consumer Protection Act

FAO Food and Agriculture Organization of the United Nations

FCS Food-contact surface

FD&C Act Federal Food, Drug, and Cosmetic Act

FSPCA Food Safety Preventive Controls Alliance

PCHF “Preventive Controls for Human Food” (requirements in 21 CFR part 117 for hazard 

analysis and risk-based preventive controls for human food in accordance with 

section 418 of the FD&C Act)

PCQI Preventive controls qualified individual

8 In the draft Chapter 3 that we made available for comment on August 24, 2016 (81 FR 57816), we used 

the terminology “undeclared allergen” rather than “unintended allergen presence,” when an allergen is 

present due to cross-contact. When we finalize that chapter, we intend to use the terminology 

“unintended allergen presence.”
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Abbreviation What It Means

WHO World Health Organization

11.3 Understand the Hazard Requiring a Preventive Control

Section 3.4.2.1 of Chapter 3 includes food allergen information such as:

• The prevalence and symptoms of food allergies; 

• The importance of susceptible consumers avoiding foods that are or contain food allergens; 

• The “major food allergens” subject to the allergen labeling requirements of the FD&C Act9

(i.e., milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and 

sesame10); 

• The presence of gluten (i.e., a mixture of proteins associated with celiac disease) in one of 

the major food allergens (i.e., wheat); and

• The classification of unintended allergen presence11 as a “chemical hazard”; and 

• The classification of an undeclared12 food allergen due to applying a label that does not 

declare all allergenic ingredients, applying the incorrect food label to a product, or using the 

wrong packaging, as a “chemical hazard.” 

Unintended allergen presence can occur through failure to prevent allergen cross-contact. 

Depending on your plant, the food products you produce, and the nature of the ingredients that 

you use, you should design your food allergen program to prevent allergen cross-contact 

between foods with different “food allergen profiles” – i.e., to prevent allergen cross-contact: 

• Between foods that contain different food allergens; and

9 For additional information about allergen labeling requirements of the FD&C Act, see section 403(w) of 

the FD&C Act (21 U.S.C. 343(w)), the definition of “major food allergen” in section 201(qq) of the FD&C 

Act (21 U.S.C. 321(qq)), our guidance regarding the allergen labeling requirements of the FD&C Act (see 

Table 11-7), and section 11.4.2. Additional regulatory information and guidance documents applicable to 

food allergens are available on our website (see Table 11-8). 

10 The allergen labeling requirements of the FD&C Act for sesame are effective for food that is introduced 

or delivered for introduction into interstate commerce on or after January 1, 2023. 11 In the draft Chapter 3 that we made available for comment on August 24, 2016 (81 FR 57816), we used 

the terminology “undeclared allergen” rather than “unintended allergen presence,” when an allergen is 

present due to cross-contact. When we finalize that chapter, we intend to use the terminology 

“unintended allergen presence” when an allergen is present due to cross-contact. 12 In contrast to “unintended allergen presence,” which we use when an allergen is present due to crosscontact, we use variations of the term “declare” when that term is used in the FD&C Act, our regulations, 

or an FDA guidance document to describe information that is present on a food label. For example, the 

label requirements in 21 CFR 101.4 for the designation of ingredients and our guidance regarding the 

allergen labeling requirements of the FD&C Act (the allergen labeling guidance; see Table 11-7 and the 

discussion in section 11.4.2) both use variations of the term “declare” when describing information 

presented on a food label. Likewise, we use variations of the term “undeclared” when describing a label 

that does not comply with label requirements in the FD&C Act or our food labeling regulations. When we 

finalize Chapter 3, we intend to explain how we use variations of the term “declare” to describe 

information that is present on a food label.
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• Between foods that contain certain food allergens and foods that do not contain any food 

allergens. 

Without such controls the food is likely to present a hazard to a consumer who has a food 

allergy. For example:

o If one beverage that you produce contains milk-derived ingredients, and a different 

beverage that you produce in that same establishment contains soy-derived ingredients, 

a food allergen program could help to prevent allergen cross-contact between the 

beverage containing milk-derived ingredients and the beverage containing soy-derived 

ingredients. Otherwise, the milk beverage could have unintended soy protein, and the 

soy beverage could have unintended milk protein. 

o If you produce some chocolate candy that contains almonds and other chocolate candy 

that does not contain almonds, a food allergen program could help to prevent allergen 

cross-contact between the chocolate candy that contains almonds and the chocolate 

candy that does not contain almonds. Otherwise, the chocolate candy that is formulated 

to not contain almonds could have unintended almonds.

o If a milk-derived food ingredient (such as whey protein powder) has the potential to 

spread to foods that do not contain milk due to the powder-based nature of the 

ingredient, a food allergen program to reduce the potential for transmission of the 

powdered ingredient (e.g., as dust) could help to prevent allergen cross-contact in foods 

that do not contain milk.

As discussed in section 3.4.2.1 of Chapter 3, food allergen hazards are a potential hazard 

regardless of whether a food allergen is present in a major ingredient (such as peanuts and tree 

nuts that are allergenic ingredients of products such as cookies and trail mix) or is an allergenic

component of a minor ingredient (such as milk that is a component of a spice blend). Therefore, 

the recommendations in this chapter apply to all raw materials and other ingredients used in the 

production of a food product, regardless of whether an allergenic ingredient is a major or minor

ingredient and regardless of whether an allergenic component is a major or minor component of 

a major of minor raw material or other ingredient in a food product.

FDA has not established a maximum amount of food allergen that may be present in labeled 

food products without need for declaration. However, FDA recognizes that published data on 

population threshold dose responses to various food allergens are becoming increasingly 

available (Remington et al., 2020; FAO/WHO, 2021 and 2022). These published data raise the 

possibility that some low-level exposures to food allergens, and the presence of certain 

allergen-derived ingredients, may not cause allergic reactions in most consumers who have that 

food allergy. Food manufacturers/processors could evaluate such data in light of their specific 

products, such as through risk assessments or other scientifically valid assessments, in making 

decisions on appropriate food allergen controls. As discussed in sections 11.8.4 and 11.9.2, 

your PCQI has the responsibility to determine the appropriate approach to the potential for 

untended allergen presence in your food product (i.e., the potential for the presence in your food 

product, due to allergen cross-contact, of a food allergen from a food source that is not already 

an ingredient in that food product).
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11.4 Considerations If You Establish and Implement a Food Allergen 

Program

11.4.1 Preventive Controls for Allergen Cross-Contact Enhance the CGMP 

Control Measures in Your Food Allergen Program

The CGMPs in part 117, subpart B specify several requirements to prevent allergen crosscontact. CGMP requirements are sometimes called a “prerequisite program” (NACMCF, 1998) 

to signify that the measures that you take to comply with the CGMP requirements should be in 

place before you conduct your hazard analysis and identify risk-based preventive controls to 

address specific hazards, such as the food allergen hazards that are the subject of this chapter. 

The allergen cross-contact controls that you establish and implement as preventive controls 

should complement and enhance the measures you have in place to comply with the CGMP 

requirements to prevent allergen cross-contact. In developing your allergen cross-contact 

controls, we recommend that you consider adapting one or more of the measures for complying 

with the CGMP requirements to function as a preventive control by combining a CGMP measure 

with one or more preventive control management components such as monitoring or verifying 

through, e.g., visual observation, after considering the nature of your food products and the role 

of a CGMP measure in your food safety system. For example:

• Section 11.6.1 of this chapter provides our recommendations for allergen cleaning 

procedures (i.e., cleaning of FCSs of equipment and utensils that are used for foods with 

different food allergen profiles), and section 11.12 of this chapter provides an example in 

which a manufacturer of frozen desserts establishes and implements allergen cleaning 

procedures as an allergen cross-contact control. Such cleaning complements and enhances

the CGMP requirements in 21 CFR 117.35 for preventing allergen cross-contact through 

sanitary operations.

• Section 11.13 of this chapter provides an example in which a bakery that produces cookies 

with and without peanuts establishes and implements allergen cross-contact controls on 

apparel, movement of personnel, utensils, and tools. These allergen cross-contact controls 

complement and enhance the CGMP requirements in 21 CFR 117.10, 117.20, and 117.40 

for preventing allergen cross-contact due to personnel, plant construction and design, and 

equipment.

• Section 11.6.2 of this chapter provides our recommendations for allergen ingredient 

procedures that you could use to complement the CGMP requirement that raw materials 

and other ingredients that are food allergens, and rework that contains food allergens, be 

identified and held in a manner that prevents allergen cross-contact. (See 21 CFR 

117.80(b)(8).) There are several ways by which you could adapt the measures you take to 

comply with this CGMP requirement to function as an allergen cross-contact control, such 

as:

o Clearly identify allergen-containing raw materials and other ingredients using a system 

that adequately distinguishes between raw materials and other ingredients with different 

food allergen profiles to alert personnel that these materials are subject to special 

precautions and handling procedures throughout the plant. An example of such a system 

is color-coding – e.g., through use of color-coded stickers/tags, placards, or shrink-wrap, 

with a specific color dedicated to each of the major food allergens and a system (such as 
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a chart displayed at multiple locations in the plant) for alerting personnel to the assigned 

colors.

o Conduct periodic verification through visual observation of the identification and storage 

of raw materials, ingredients, and rework, document the results of your visual 

observations, and document corrective actions (or, when applicable, corrections) that 

you take if your observations indicate that food allergens in raw materials or other 

ingredients have not been identified (e.g., if a color-coding system that you establish was 

not properly implemented) or that these materials are not stored properly (e.g., if bags 

containing soy protein are not completely closed or if there is spillage of powder in the 

storage area).

o Monitor or verify that the allergenic ingredients brought to the staging area for the recipe 

or formulation of the scheduled product match the product label content by inspecting 

the ingredient labels (or stickers/tags on ingredients if, for example, you have used colorcoded stickers/tags to identify allergenic-containing ingredients) and reconciling allergenrelated information on the ingredient labels (or stickers/tags) with the product label or the 

product specifications (i.e., in the recipe or formulation).

• The CGMPs require that WIP and rework be handled in a manner that protects against 

allergen cross-contact. (See 21 CFR 117.80(c)(5).) One way to adapt the measures you 

take to comply with this CGMP requirement to function as an allergen cross-contact control 

is to establish and implement written procedures to manage re-entry of WIP and rework 

(e.g., during release of WIP and rework from storage areas, during the staging and transfer 

of WIP and rework, and at the re-entry points for WIP and rework in the production process). 

You then could monitor activities such as re-entry of rework and WIP (e.g., by recording the 

amount used, the product in which the WIP or rework was used, the lot number, and 

reconciliation of the amount used with the total amount produced), and document any 

corrective actions (or, when applicable, corrections) if a problem occurs.

Importantly, a food allergen program generally is used in combination with the sanitation 

controls required by 21 CFR 117.135(c)(3). The allergen cleaning procedures that we 

recommend in section 11.6.1 are similar to the sanitation controls that are the subject of 

Chapter 10, with targeted recommendations specific to the removal of allergenic residues and, 

thus, the prevention of allergen cross-contact.

11.4.2 Foods That Contain a Major Food Allergen Are Subject to the 

Allergen Labeling Requirements of the FD&C Act

Section 403(w) of the FD&C Act (21 U.S.C 343(w)) contains requirements (the “allergen labeling 

requirements of the FD&C Act”) that apply to certain foods that are, or contain, a major food 

allergen. Our guidance regarding the allergen labeling requirements of the FD&C Act (the 

allergen labeling guidance; see Table 11-7) provides information to help you comply with the 

allergen labeling requirements of the FD&C Act. One such labeling requirement is to name the 

food source of all major food allergens used as ingredients in the packaged food. As discussed 

in the allergen labeling guidance, this can be done in one of two ways. The first option is for you 

to include the name of the food source in parentheses following the common or usual name of 

the major food allergen in the list of ingredients in instances when the name of the food source 

of the major allergen does not appear elsewhere in the ingredient statement (e.g., Sugar, whey 

(milk), eggs). The second option is to use a “Contains” statement followed by the names of the 

food sources from which all major food allergens are derived (e.g., “Contains egg and milk”,

“Contains egg”) immediately after or adjacent to the list of ingredients. Importantly, a “Contains” 

statement includes the names of the food sources of all major food allergens used as 
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ingredients in the packaged food. See the allergen labeling guidance for more details about how 

to meet the allergen labeling requirements of the FD&C Act.

13

11.4.3 Policy Statements and Other Guidance Regarding Allergen Labeling

Our web page providing guidance documents and regulatory information regarding food 

allergens (see Table 11-8) provides policy statements and other guidance issued by FDA 

regarding allergen labeling. For example:

• The 1996 food allergen notice (see Table 11-8) advised the food industry that, because 

adhering to CGMPs is essential for effective reduction of adverse reactions by consumers, 

labeling such as “may contain [allergen]” should not be used in lieu of adherence to CGMPs 

and urged manufacturers to take all steps necessary to eliminate cross-contamination and 

to ensure the absence of the identified food. 

• Question/Answer D.14 in our allergen labeling guidance advises that:

o Labeling such as “may contain [allergen]” is not a substitute for adherence to CGMPs 

and food allergen preventive controls; and

o Any statement such as “may contain [allergen]” must be truthful and not misleading; 

• Question/Answer D.13 in our draft allergen labeling guidance14 advises that the food 

allergen labeling requirements of the FD&C Act do not apply to a major food allergen that is 

unintentionally incorporated in a food as a result of cross-contact; and

• Our Compliance Policy Guide (CPG) entitled “CPG Sec. 555.250 Statement of Policy for 

Labeling and Preventing Cross-contact of Common Food Allergens” (see Table 11-6)

describes various labeling requirements and policies15,16.

You should periodically check FDA’s website for updates to our policy statements and other 

guidance regarding allergen labeling. 

13 Note that our regulation in 21 CFR 101.91 defines the term ‘‘gluten-free’’ for voluntary use in the 

labeling of foods. A food label that includes the term ‘‘wheat’’ in the ingredient list or in a separate 

‘‘Contains wheat’’ statement as required by the allergen labeling requirements of the FD&C Act and also 

bears the claim ‘‘gluten-free’’ will be deemed to be misbranded unless its labeling also bears additional 

language clarifying that the wheat has been processed to allow the food to meet FDA requirements for a 

‘‘gluten-free’’ claim.

14 The draft allergen labeling guidance, when finalized, will explain FDA’s current thinking on a number of 

issues related to the labeling of food allergens, including requirements in both FALCPA and the FASTER 

Act.

15 CPG Sec. 555.250 also discusses practices used to prevent potential allergen cross-contact. 16 In 2023, FDA issued for public comment a draft compliance policy guide entitled “CPG Sec. 555.250 

DRAFT: Major Food Allergen Labeling and Cross-contact” (88 FR 31507, May 17, 2023). When finalized, 

this draft CPG will replace existing guidance, in CPG Sec. 555.250 Statement of Policy for Labeling and 

Preventing Cross-contact of Common Food Allergens, for FDA staff on FDA’s enforcement policy 

regarding major food allergen labeling and cross-contact.
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11.5 Develop a Strategy for Preventive Control Management 

Components

11.5.1 Overview of Preventive Control Management Components

With few exceptions, part 117 specifies that preventive controls are subject to the following 

preventive control management components as appropriate to ensure the effectiveness of the 

preventive controls, taking into account the nature of the preventive control and its role in the 

facility’s food safety system: (1) Monitoring; (2) corrective actions and corrections; and (3) 

verification. (See 21 CFR 117.140.)

This chapter describes our recommendations for three types of preventive controls that are 

subject to preventive control management components:

• Allergen cross-contact controls; 

• Label controls17; and

• Supply-chain controls for raw materials and other ingredients when a food allergen hazard in 

the raw material or other ingredient is controlled before its receipt. 

Our recommended CGMP measures in Appendix 11-1 to prevent allergen cross-contact are not 

subject to preventive control management components. However, as discussed in section

11.4.1, you could develop and implement appropriate preventive control management 

components for any CGMP measure that you adapt to function as a preventive control.

11.5.2 Monitoring and Verification

11.5.2.1 Requirements for monitoring

Part 117 requires that, as appropriate to the nature of the preventive control and its role in your 

food safety system, you establish and implement written procedures, including the frequency 

with which they are to be performed, for monitoring the preventive control. (See 21 CFR 

117.145(a).) You must monitor the preventive controls with adequate frequency to provide 

assurance that they are consistently performed. (See 21 CFR 117.145(b).) See section 11.5.6

for a discussion of the requirements of part 117 for records of monitoring activities.

11.5.2.2 Requirements for verification

Part 117 requires that verification activities include, as appropriate to the nature of the 

preventive control and its role in your food safety system: (1) Validation18; (2) Verification that 

17 Section 11.7 provides separate recommendations for “label content controls” and “label management 

controls.” However, we do so solely as an organizational tool for presenting our recommendations for how 

to use label controls to prevent food from being misbranded under section 403(w) of the FD&C Act. In 

your food safety plan, it makes no difference whether you classify your label control as a control on label 

content or a control on managing your labels. Thus, when you tailor this guidance for your operations you 

may find it more useful to classify a label control in a different manner than we do in this chapter. 18 During the rulemaking to establish part 117, we acknowledged that it is premature to require validation 

of food allergen controls (see the discussion in the proposed rule (78 FR 3646 at 3755, January 16, 2013) 

and Response 515 in the final rule (80 FR 55908 at 56058)). As a result, part 117 does not require 
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monitoring is being conducted; (3) Verification that appropriate decisions about corrective 

actions are being made; (4) Verification of implementation and effectiveness; and (5) 

Reanalysis. (See 21 CFR 117.155.)

Part 117 requires that you verify that the preventive controls are consistently implemented and 

are effectively and significantly minimizing or preventing the hazards. To do so you must 

conduct activities that include the following, as appropriate to the facility, the food, and the 

nature of the preventive control and its role in the facility’s food safety system: (1) Calibration of 

process monitoring instruments and verification instruments (or checking them for accuracy); 

and (2) Review of certain records by (or under the oversight of) a PCQI, to ensure that the 

records are complete, the activities reflected in the records occurred in accordance with the food 

safety plan, the preventive controls are effective, and appropriate decisions were made about 

corrective actions. (See 21 CFR 117.165(a)(1) and (4).)

Part 117 also requires, as appropriate to the facility, the food, the nature of the preventive 

control, and the role of the preventive control in the facility’s food safety system, that you 

establish and implement written procedures for the method and frequency of calibrating process 

monitoring instruments and verification instruments (or checking them for accuracy). (See 21 

CFR 117.165(b)(1).)

See section 11.5.5 for a discussion of reanalysis. See section 11.5.6 for a discussion of the 

requirements of part 117 for records of verification activities.

11.5.2.3 Flexibility in complying with the requirements for monitoring 

and verification for allergen cross-contact controls and label controls

The requirements for monitoring provide flexibility for you to establish and implement written 

procedures for monitoring preventive controls as appropriate to the nature of the preventive 

control and its role in your food safety system. (See 21 CFR 117.145.) Likewise, the 

requirements for verification provide flexibility for you to conduct verification activities that are 

appropriate to the facility, the food, and the nature of the preventive control and its role in the 

facility’s food safety system. (See 21 CFR 117.165.) In many cases, the nature of an activity 

(such as visual observation) conducted as a preventive control management component for an 

allergen cross-contact control or a label control could be classified as either monitoring or as 

verification. In light of the flexibility that part 117 provides for monitoring and verification, it 

generally makes little difference whether you consider such an activity to be monitoring or 

verification for the purposes of your allergen program as long as you comply with requirements 

applicable to monitoring or verification; part 117 does not require that you establish and 

implement both a monitoring activity and a verification activity if the same activity (such as visual 

observation) would be used as both a monitoring activity and a verification activity. Regardless 

of what you call them, you must have procedures that are adequate to ensure the effectiveness 

of the preventive controls.

validation of food allergen controls (see 21 CFR 117.160(c)(1)). Therefore, this guidance does not provide 

recommendations for validation of food allergen controls. However, nothing in part 117 would prevent you 

from validating a food allergen control, if you choose to do so (see Response 513, 80 FR 55908 at 

56057), and some verification procedures that we describe in this chapter could, with minimal 

modification, be part of a validation study. (See the discussion in Response 515, 80 FR 55908 at 56058.)
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11.5.3 Corrective Actions and Corrections

Part 117 includes requirements, as appropriate to the nature of the hazard and the nature of the 

preventive control, for corrective action procedures that must be taken if a preventive control is 

not properly implemented. (See 21 CFR 117.150(a)(1).) The corrective action procedures must 

describe the steps to be taken to ensure that: (1) Appropriate action is taken to identify and 

correct the problem; (2) appropriate action is taken, when necessary, to reduce the likelihood 

that the problem will recur; (3) all affected food is evaluated for safety; and (4) all affected food 

is prevented from entering into commerce, if you cannot ensure that the affected food is not 

adulterated or misbranded. (See 21 CFR 117.150(a)(2).)

However, you do not need to take corrective actions if you take action, in a timely manner, to 

identify and correct conditions and practices that are not consistent with the food allergen 

controls in 21 CFR 117.135(c)(2)(i) (ensuring protection of food from allergen cross-contact), or 

if you take action, in a timely manner, to identify and correct a minor and isolated problem that 

does not directly impact product safety (i.e., make corrections). (See 21 CFR 117.150(c).) For 

example, if you observe that a CIP system failed to maintain its target temperature, and you 

correct the problem by determining the root cause of the problem, adjusting the temperature 

and running a complete CIP at the appropriate temperature before beginning production, you 

could consider that your prompt action corrects conditions and practices that are not consistent 

with your allergen cross-contact controls. As another example, if a problem occurs with a label 

control before a product label is applied or used in food production and you fix the problem so 

that only correct labels are used, you could consider the problem to be a minor problem that 

does not directly impact product safety.

See section 11.5.6 for a discussion of the requirements of part 117 for records of corrective 

actions and corrections.

11.5.4 Applying Preventive Control Management Components to SupplyChain Controls 

The supply-chain program required by part 117, subpart G includes specific requirements 

applicable to supplier verification activities, and the supply-chain program as a whole is subject 

to a subset of preventive control management components – i.e., corrective actions and 

corrections, review of records, and reanalysis. (See 21 CFR 117.140(b).)

11.5.5 Reanalysis

Part 117 includes requirements for you to conduct a reanalysis of the food safety plan as a 

whole at least once every 3 years. (See 21 CFR 117.170(a).) Part 117 also includes 

requirements for you to conduct a reanalysis of the food safety plan as a whole, or the 

applicable portion of the food safety plan: (1) Whenever a significant change in the activities 

conducted at your facility creates a reasonable potential for a new hazard or creates a 

significant increase in a previously identified hazard; (2) whenever you become aware of new 

information about potential hazards associated with the food; (3) whenever appropriate after an 

unanticipated food safety problem; and (4) whenever you find that a preventive control, 

combination of preventive controls, or the food safety plan as a whole is ineffective. (See 21 

CFR 117.170(b).)

See the discussions in sections 11.6.1.3, 11.6.2, 11.7.4, and 11.8.6 regarding circumstances in 

which reanalysis of your food safety plan is warranted in light of ongoing problems with your 
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allergen cross-contact controls, label controls, or supply-chain program, respectively. See the 

discussion in section 11.9.5 regarding reanalysis of your determination regarding allergen 

advisory statements.

11.5.6 Records Documenting the Preventive Control Management 

Components

Part 117 requires that you document the preventive control management components as 

follows: 

• The monitoring of preventive controls in records that are subject to verification and records 

review. (See 21 CFR 117.145(c)(1).) However, part 117 provides flexibility for records of 

monitoring to be “exception records” - i.e., records that you establish only when there is loss 

of control. (See 21 CFR 117.145(c)(2).) See the discussion in section 11.7.5 of an example 

of exception records relevant to a label control.

• All corrective actions (and, when appropriate, corrections) in records that are subject to 

verification and records review. (See 21 CFR 117.150(d).)

• All verification activities in records that are subject to records review. (See 21 CFR 

117.155(b) and 117.165(a)(4).)

11.6 Allergen Cross-contact Controls

11.6.1 Allergen Cleaning Procedures

As discussed in section 11.4.1, your allergen cross-contact controls should complement the 

measures you take to comply with the CGMP requirements of part 117, subpart B for preventing 

allergen cross-contact. In this chapter, we discuss allergen cleaning procedures as an allergen 

cross-contact control19 that can complement the measures that you take to comply with the 

CGMP requirement that all FCSs, including utensils and FCSs of equipment, must be cleaned 

as frequently as necessary to protect against allergen cross-contact. (See 21 CFR 117.35(d).) 

As with all preventive controls, the allergen cleaning procedures must be written. (See 21 CFR 

117.135(b).)

Procedures for monitoring preventive controls also must be written. (See 21 CFR 117.145(a).)

Note that a form that you would use to document a monitoring activity could function as a written 

procedure for the monitoring activity, because the person who conducts the monitoring could 

use the form as a guide for what to monitor. Likewise, if you will establish any written verification 

or corrective action procedures, a form that you would use to document the verification activity 

or corrective actions could function as a written procedure for the verification activity or the 

corrective actions, because the person who conducts the verification activity or is responsible 

19 Alternatively, you could consider such cleaning to be a sanitation control established to satisfy the 

requirements of 21 CFR 117.135(c)(3)(ii). In addition, as already discussed in section 11.4, you could 

consider adapting one or more of the measures for complying with the CGMP requirements to prevent 

allergen cross-contact (e.g., the measures discussed in Appendix 11-1) to function as a preventive control 

by combining a CGMP measure to prevent allergen cross-contact with one or more preventive control 

management components such as monitoring or verifying through, e.g., visual observation, and 

appropriate records.
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for the corrective actions could use the form as a guide for what to verify and the steps to take 

to comply with the requirements for corrective actions.

We recommend that you keep the required written procedures for monitoring the allergen 

cleaning procedures, and any written verification or corrective action procedures that you 

establish for the allergen cleaning procedures, together with your allergen cleaning procedures, 

because doing so would help communicate the overall framework and goals of the allergen 

cleaning procedures. In the remainder of this document, we use the term sanitation standard 

operating procedure (SSOP) to refer to a document that includes all procedures and forms 

applicable to allergen cleaning procedures that you establish and implement as a preventive 

control. 

We recommend that your SSOP for allergen cleaning procedures include the following as 

appropriate to the type of cleaning process (e.g., dry cleaning or wet cleaning) and the design of 

the equipment or utensil to be cleaned:

• The purpose of the cleaning procedure (e.g., its role in preventing allergen cross-contact);

• The frequency of cleaning (e.g., how often the cleaning is to be conducted and the temporal 

relationship to changeover of a production line);

• Who is responsible for performing the cleaning procedure;

• Instructions to perform the specific cleaning procedure, including:

o Types of cleaning agents to be used for specific equipment and utensils;

o Concentration of cleaning agents used in wet cleaning;

o Equipment and tools to be used during the cleaning procedure; and

o Specific instructions for cleaning, such as the sequence of steps and whether 

disassembly of equipment is required;20

• A list of monitoring/verification activities that will be performed and any written procedures 

that you establish for those activities;

• Corrections or corrective actions to take when the cleaning procedure is not properly 

implemented; and 

• Any forms that you will use to document monitoring/verification of the cleaning procedure,

corrections, or corrective actions.

11.6.1.1 Monitoring and Verification for Allergen Cleaning Procedures

As discussed in section 11.5, you have flexibility to apply preventive control management 

components as appropriate to ensure the effectiveness of the preventive controls, and the 

nature of an allergen cross-contact control is such that in some cases an activity could be 

classified as either a monitoring activity or a verification activity, as long as you comply with 

20 For example, in wet cleaning operations a common sequence of operations is Pre-clean (e.g., scraping 

to remove foods), Pre-rinse, Apply detergent and Scour, Post-Rinse, Prepare for Inspection, Pre-op 

Inspection, Sanitize, and Assemble. In dry cleaning operations, where the objective is to minimize the use 

of water in the area to prevent the growth of microorganisms such as Salmonella, tools such as vacuum 

cleaners, brooms, brushes, and wipes are commonly used.
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requirements applicable to monitoring or verification. For example, observing whether an FCS is 

visibly clean generally could be classified as either a monitoring activity or a verification activity.

In other cases, a preventive control management activity for an allergen cross-contact control 

would commonly be considered a monitoring activity rather than a verification activity. For 

example, checking the temperature of water used during a wet cleaning operation generally is 

classified as monitoring. Likewise, in some cases a preventive control management activity for 

an allergen cross-contact control would commonly be considered a verification activity rather 

than a monitoring activity. For example, part 117 classifies calibration as a verification activity

(see 21 CFR 117.165(a)(1)).

You have flexibility to determine what monitoring/verification activities, and how many 

monitoring/verification activities, are appropriate for your operation to ensure the effectiveness 

of the preventive control. (See 21 CFR 117.140(a).) For example, in some cases you could 

determine to monitor the steps of a cleaning process but not verify the cleaning process by 

swabbing surfaces to detect food residues that remain after cleaning. In addition, you can 

classify observations of steps in the cleaning process to be either monitoring or verification. 

However, regardless of whether you classify a specific activity as monitoring or as verification, 

the nature and number of activities you conduct must be adequate to ensure the effectiveness 

of the preventive control. (See 21 CFR 117.140(a)). In addition, you must verify the results of 

that activity by reviewing applicable records. (See 21 CFR 117.165(a)(4).)

In this section of this chapter, we provide a combined list of examples of monitoring and 

verification activities without classifying the activities as either monitoring or verification. See 

section 11.12 for an example of how a manufacturer that establishes and implements an 

allergen cross-contact control could classify specific activities as monitoring or verification 

activities.

The specific activity to be monitored or verified depends on the type of cleaning procedure

(e.g., wet cleaning or dry cleaning). Examples of monitoring and verification activities are:

• Checking the makeup of a cleaning solution (e.g., the amount of cleaning chemical added to 

a specified amount of water or the presence of active ingredient of a cleaning chemical in a 

specified amount of water) in a wet-cleaning operation;

• Recording the date and time of cleaning of equipment during a changeover from an 

allergen-containing product to a product that does not contain that food allergen; 

• Using a checklist to document each step of the cleaning procedure as it is performed;

• Observing each step in the cleaning process as it is being conducted (e.g., by a sanitation 

supervisor);

• Observing that an automatic cycle begins and ends (e.g., when using automatic equipment 

such as a clean-in-place (CIP) system);

• Calibrating an automated cleaning system to ensure appropriate temperatures and cleaning 

agent concentrations if these are critical to removal of the food allergen;

• Observing that the production equipment is visibly clean (e.g., at the end of cleaning or as 

part of a pre-operational inspection just prior to production), taking into account the nature of 

the FCSs (e.g., materials from which the FCSs are constructed);
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• Using rapid ATP (adenosine triphosphate) swabs, protein swabs, or allergen-specific test 

kits to detect food residues that remain after cleaning;21

• Periodically using an allergen‐specific test kit (if one is available for the food allergen(s) of 

interest in the matrix of your food product) to detect the presence of food allergens 

remaining on food‐contact surfaces after cleaning by using swabs or testing final rinse water 

(e.g., the final rinse of a CIP cycle for equipment that is wet cleaned). If your production 

procedure includes a “push-through” technique in which the subsequent product, an inert 

ingredient (such as sugar or salt), or an allergen-containing ingredient (such as flour) that 

will be an ingredient in the subsequent product is pushed through the system to remove 

traces of food residue, you could use test kits to evaluate “push-through” material, or the first 

product through the line, to demonstrate that a food allergen from a previous production run 

has been removed; and

• Reviewing the monitoring/verification records in accordance with 21 CFR 117.165(a)(4).

11.6.1.2 Corrective Actions and Corrections for Allergen Cleaning

Procedures

When cleaning procedures used to control allergen cross-contact have not been properly 

implemented, you must implement corrections or take corrective actions in accordance with 

your corrective action procedures. (See 21 CFR 117.150.) 

• An example of when a correction can suffice is an observation that a CIP system failed to 

maintain its target temperature, if you correct the problem by adjusting the temperature and 

running a complete CIP at the appropriate temperature before beginning production. (See 

21 CFR 117.150(c)(1), which provides that you do not need to take corrective actions if you 

take action, in a timely manner, to identify and correct conditions and practices that are not 

consistent with the allergen cross-contact controls.) 

• An example of when a corrective action is warranted is finding the presence of a food 

allergen during periodic testing of FCSs using an allergen test kit. The detection of the food 

allergen could be an indication either that the cleaning procedure was not properly 

implemented or that the cleaning procedure is not effective at removing the food allergen. In 

such a situation, corrective actions would include:

o Identifying the problem (e.g., determining whether the food residue was detected 

because the cleaning procedure was not properly implemented or because the cleaning 

procedure was not effective);

o Correcting the problem and reducing the likelihood that the problem will recur (e.g., by 

re-training employees in how to use the cleaning procedure or by revising the cleaning 

procedure to improve its effectiveness); and

o Determining whether food is affected and, if so, evaluating that food for safety, and 

ensuring that the food with an unintended allergen does not enter commerce (or that any 

21 Note that ATP tests are considered “non-specific” tests for cleanliness because ATP is found in all 

living cells and its presence could reflect diverse sources such as food, microorganisms, or even human 

skin. ATP tests and other “non-specific” tests (such as tests that would detect any protein rather than a 

specific protein) have the potential to be more sensitive than visual observation but may not be sensitive 

enough to detect levels of a particular allergenic protein.
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such food that has entered commerce is recalled). In determining which food is affected, 

we recommend that you consider all food lots produced from cleanup to cleanup.

We recommend that your corrective action procedures distinguish between those corrective 

actions you would take if you determine that the problem was due to improper implementation of 

the allergen cleaning procedure and those corrective actions you would take if you determine 

that the allergen cleaning procedure is not effective. For example, if an occasional finding of 

product residue on a cleaned FCS leads you to determine that the allergen cleaning procedure 

was not properly implemented, you could limit your corrective action procedures to retraining the 

personnel who conduct the cleaning. However, if repeated findings of product residue on a 

cleaned FCS lead you to determine that the cleaning procedure is not effective, your corrective 

action procedures should include reanalysis of your food safety plan to determine whether to 

revise your allergen cleaning procedures. (See the discussion of reanalysis in section 11.6.1.3.)

11.6.1.3 Reanalysis of Your Allergen Cleaning Procedures

As discussed in section 11.5.5, part 117 includes requirements for you to conduct a reanalysis 

of the food safety plan as a whole, or the applicable portion of the food safety plan, whenever 

you find that a preventive control, combination of preventive controls, or the food safety plan as 

a whole is ineffective, or at least every 3 years. (See 21 CFR 117.170(b)(4).) Reanalysis of your 

allergen cleaning procedures is appropriate if, for example, repeated findings of product residue 

on a cleaned FCS lead you to determine that the cleaning procedure is not effective. 

See the discussions of allergen advisory statements in section 11.9. In some circumstances, 

reanalysis of your allergen cleaning procedures could lead you to conclude that allergen 

advisory statements are appropriate because, despite using appropriate CGMPs and preventive 

controls, residues or allergen cross-contact cannot be avoided.

11.6.1.4 Records Documenting Allergen Cleaning Procedures and 

Applicable Preventive Control Management Components

Your allergen cross-contact controls for cleaning are preventive controls and, thus, you must 

have a record of the allergen cleaning procedures (such as in the SSOP discussed in this

chapter). (See 21 CFR 117.135(b) and 117.126(b)(2).)

Records of monitoring and verification activities may be created manually or automatically (e.g., 

if a computer record is generated automatically when a CIP system is used). For manual 

records, we recommend that you use standardized forms and checklists, as appropriate to the 

activity being monitored or verified, because such forms can help ensure that the activities are 

conducted in a consistent manner.

As noted in section 11.5.6, exception records for monitoring may be adequate in some 

circumstances. (See 21 CFR 117.145(c)(2)(ii).) 

You must document all corrective actions and, as appropriate, corrections. (See 21 CFR 

117.150(d).) To document corrective actions, you would describe the problem, how it was 

corrected (including steps you will take to prevent it from happening again, and the evaluation 

and disposition of any affected food). An example of when it would be appropriate to document 

corrections is when you want to be able to determine patterns that could suggest improvements 

to your procedures. For example, if you use a checklist to monitor whether equipment is clean

during a pre-operational inspection before beginning production, a review of corrections noted 
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on the checklists could help to identify a pattern of problems such that a change to the cleaning 

procedure would be warranted.

All verification activities must be documented. (See 21 CFR 117.155(b).) One way to document

a record review that you conduct to satisfy the requirements of 21 CFR 117.165(a)(4) is for your 

PCQI (or designee) to sign or initial, and date, the primary monitoring, corrective action, and 

verification records.

11.6.2 Allergen Ingredient Procedures

As discussed in section 11.4.1, your allergen cross-contact controls should complement the 

measures you take to comply with the CGMP requirements of part 117, subpart B for preventing 

allergen cross-contact. In this chapter, we discuss allergen ingredient procedures as an allergen 

cross-contact control that can complement the measures that you take to comply with the 

CGMP requirement that raw materials and other ingredients that are food allergens, and rework 

that contains food allergens, be identified and held in a manner that prevents allergen crosscontact. (See 21 CFR 117.80(b)(8).) Allergen cross-contact can result from the unintentional 

addition of the wrong ingredient to a food; allergen ingredient procedures can prevent such 

unintentional addition.

Allergen ingredient procedures could be particularly useful when it is not readily apparent, to 

production personnel or to consumers, that an ingredient is or contains a food allergen. In some 

food products, production personnel add a flavor ingredient such as a seasoning mix to the food 

based on the recipe or formulation of the finished food (e.g., a flavor added to chips), whereas in 

other food products a consumer adds a flavor packet that is provided separately in a packaged 

food product during preparation of that food product. It may not be readily apparent to 

production personnel and consumers in such circumstances that the seasoning mix contains a 

flavor ingredient such as soy.

If your PCQI determines that you must identify and implement allergen ingredient procedures to 

provide assurances that food allergen hazards requiring a preventive control will be significantly 

minimized or prevented and the food manufactured, processed, packed, or held by your facility 

will not be adulterated under section 402 of the FD&C Act, we recommend that you tailor those 

procedures to your facility and your operations. For example, the preventive control, and 

associated monitoring or verification activities, would depend on factors such as where and 

when you transfer ingredients from their original packaging to containers used in production, 

and how you identify ingredients after you have transferred them from their original packaging.

As with allergen cleaning procedures, when allergen ingredient procedures have not been 

properly implemented, you must implement corrections or take corrective actions in accordance 

with your corrective action procedures. (See 21 CFR 117.150).) 

• An example of when a correction can suffice is an observation that the wrong ingredient has 

been brought to the staging or production area before that ingredient is used in production.

(See 21 CFR 117.150(c)(1), which provides that you do not need to take corrective actions if 

you take action, in a timely manner, to identify and correct conditions and practices that are 

not consistent with the allergen cross-contact controls.) 

• An example of when a corrective action is warranted is a determination that an incorrect 

ingredient, containing an allergen not otherwise included as an ingredient of the food, was 

added to the food during production. In such a situation, corrective actions would include:
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o Identifying the problem (e.g., determining whether the allergenic ingredient was added 

because the allergen ingredient procedures were not properly implemented or because 

the allergen ingredient procedures were not effective); 

o Correcting the problem and reducing the likelihood that the problem will recur (e.g., by 

re-training employees in how to use the allergen ingredient procedures or by revising the 

allergen ingredient procedures to improve their effectiveness); and

o Determining whether food is affected and, if so, evaluating that food for safety, and 

ensuring that food with unintended allergen presence (which would not be listed on the 

label) does not enter commerce (or that any such food that has entered commerce is 

recalled).

Reanalysis of your allergen ingredient procedures is appropriate if, for example, repeated 

findings that an allergenic ingredient was unintentionally added to your food product lead you to 

determine that the allergen ingredient procedures are not effective.

As with all preventive controls, the allergen ingredient procedures and any associated 

monitoring procedures must be written. (See 21 CFR 117.135(b) and 117.145(a).)

11.7 Label Controls

11.7.1 Preventive Controls for the Content of the Product Label and for 

Managing Labels

To ensure that a finished food is not misbranded under section 403(w) of the FD&C Act, we 

recommend that your label controls provide assurance that:

• The product label correctly names the food source of all ingredients that are, or contain, a 

major food allergen in the manner described by the allergen labeling requirements of the 

FD&C Act and includes all ingredients that are, or contain, a major food allergen; and

• The correct label is applied to the correct product in that the label applied to the product 

during production matches the ingredient specifications (i.e., in the recipe or formulation) of 

the product being manufactured/processed.

To do so, we recommend that you establish and implement label controls and associated 

preventive control management components for:

• The content of the product label at the following stages:

o Development of labels; 

o Ordering labels; 

o Production of labels; and

o Receipt of labels.

22

• Managing printed labels, including storage, use, and disposition of product labels at the 

following stages:

o Storage of labels; 

22 At some stages, such as receipt of labels, it is likely that you would monitor or verify a label control 

established at an earlier stage, e.g., production of labels, rather than establish a label control.
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o Food production (including staging and packaging/labeling); and

o Post-production. 

In this chapter, we provide separate recommendations for “label content controls” and “label 

management controls.” However, we do so solely as an organizational tool for presenting our 

recommendations for how to use label controls to prevent food from being misbranded under 

section 403(w). In your food safety plan, label content controls and label management controls 

will be very inter-related, and it makes no difference whether you classify your label control as a 

label content control or a label management control. In addition, in some cases you could have 

two label controls (i.e., one for label content and another for label management), with a single 

monitoring/verification activity, documented by a single record, for both label controls. Thus, 

when you tailor this guidance for your operations you may find it more useful to classify a label 

control in a different manner than we do in this chapter, and to have fewer 

monitoring/verification activities, and fewer records, than the activities and records that we 

describe in this chapter. Our purpose is to provide as many examples as possible so that you 

can develop your own food allergen program as appropriate to your operations, not to imply that 

a food allergen program should have all the controls, monitoring/verification activities, and 

records that we describe for illustrative purposes.

We recommend that you apply such label controls to pre-printed labels that you receive, as well 

as to labels that you generate yourself, regardless of whether the product label is a label that 

you would apply to the packaged food product or is pre-printed on the package itself.

You are required to have written procedures for your label controls23 and for monitoring your 

label controls. (21 CFR 117.135(b) and 117.145(a).) We recommend that you organize any 

written procedures for controls on the content of the product label in a manner that will help 

communicate the overall framework and goals of these controls. For example, you could 

organize your procedures that address development of labels, ordering labels, production of 

labels, and receipt of labels, and associated preventive control management components (such 

as monitoring procedures), in a single document, or collect them in one file or folder. In this 

document, we refer to such procedures as the “Label Content Procedures.”

Likewise, we recommend that you organize any written procedures for controls for the 

management of product labels/packages, and for associated preventive control management 

components (such as monitoring procedures), in a single document, file or folder, because 

doing so will help communicate the overall framework and goals of these controls. In this 

document, we refer to such procedures as the "Label Management Procedures.”

As with allergen cross-contact controls, a form that you would use to document a monitoring 

activity could function as a written procedure for the monitoring activity, because the person who 

conducts the monitoring could use the form as a guide for what to monitor. Likewise, if you will 

establish any written verification or corrective action procedures, a form that you would use to 

document the verification activity or corrective actions could function as a written procedure for 

the verification activity or the corrective actions, because the person who conducts the 

verification activity or is responsible for the corrective actions could use the form as a guide for 

what to verify and the steps to take to comply with the requirements for corrective actions.

23 The requirement for you to have written procedures for your preventive controls applies even if a third 

party helps you to establish and implement those written procedures.
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11.7.1.1 Label controls for the content of the product label

11.7.1.1.1 Label development stage

You can develop the product label yourself or you can arrange for a third party (e.g., a label 

design specialist or company) to develop the product label. Complete label content 

requirements are beyond the scope of this chapter; the focus here is the labeling related to food 

allergens. Examples of what your Label Content Procedures could address at the label 

development stage are:

• Procedures for developing the food allergen label specification for the product label to 

ensure that the finished food will not be misbranded under section 403(w) of the FD&C Act, 

such as:

o Identifying the allergenic ingredients (e.g., peanuts) in the product specification (i.e., the 

recipe or formulation);

o Identifying any allergenic components in the raw materials and other ingredients 

obtained from a supplier, e.g.:

 If a spice blend you will add as an ingredient has a milk-derived component; or 

 If your supplier provides an allergen advisory statement for an ingredient you receive 

from that supplier and your PCQI determines and documents that an allergen 

advisory statement should be carried through on any of your own products; and

o Your approach (e.g., through the ingredient statement or through a “Contains”

statement) to satisfying the allergen labeling requirements of the FD&C Act to name the 

food source of any major food allergen that is:

 An ingredient of your food product; or 

 An allergenic component of an ingredient in your food product; and

o When applicable, your PCQI’s:

 Written justification for why allergen cross-contact controls cannot ensure protection 

of food from allergen cross-contact during manufacture of your food product and, 

thus, that allergen advisory statements are appropriate (see section 11.9.2); and 

 Written determination regarding your approach to allergen advisory statements when 

a supplier provides an allergen advisory statement for an ingredient that you use in a 

food product (see section 11.9.3).

• When useful for your operation, the use of an identity coding system for printed labels and 

packages (e.g., color codes that are easy to visualize, such as colored striping on labels that 

will be stacked flat in packaging machines). The utility of such an identity coding system 

largely depends on the nature of the package/label and the packaging/labeling operation. 

11.7.1.1.2 Ordering stage for labels

If you will order pre-printed product labels (or packages that contain pre-printed product labels) 

from a vendor, examples of what your Label Content Procedures could address at the ordering 

stage are:
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• Specifying in the written purchase document the specific text of the food allergen label

specification to satisfy the allergen labeling requirements of the FD&C Act to name the food 

source of any ingredients that are, or contain, a major food allergen; 

• Specifying in the written purchase document that “proofs” or samples of product labels need 

to be provided for your review before you authorize the initial production run of pre-printed 

product labels; and

• Specifying in the written purchase document any necessary procedures to minimize the 

potential for commingling product labels for different products. For example, one such 

procedure is to use separate pallets for labels for different products, where practical.

Alternatively, a copy of the label could be pasted on the outside of each box of labels or 

packages. 

11.7.1.1.3 Label production stage for labels that you generate 

If you will use computer-generated product labels that you print yourself, examples of what your 

Label Content Procedures could address at the label production stage for the computergenerated labels are procedures for:

• Checking that the correct electronic file for the label is used; and 

• Limiting the number of personnel who are authorized to edit electronic files for product 

labels.

11.7.1.2 Label controls for managing product labels/packages

11.7.1.2.1 Storage stage

Examples of what your Label Management Procedures could address at the storage stage are 

procedures for:

• Avoiding commingling of product labels/packages for different products (e.g., on pallets or 

shelves where you store labels that you receive or that you generate yourself); 

• Posting a copy of the product labels on the storage bins or shelves where they are stored; 

and

• Timely disposal of out-of-date product labels/packages. 

11.7.1.2.2 Production (staging) stage

Examples of what your Label Management Procedures could address at the production 

(staging) stage are procedures for:

• Checking a sample of the product label (or product package, if the label is pre-printed on the 

product package) to ensure that it is the correct label/package for the product before placing 

a roll or stack of labels or packaging with pre-printed labels in the staging area; and
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• Ensuring that either the only labels in the product labeling/packaging area are for the 

product being placed in a package at that time, or that the labels/packaging are 

appropriately identified or aligned so they will only be transferred to the appropriate 

production line.

11.7.1.2.3 Post-production stage

Examples of what your Label Management Procedures could address at the post-production 

stage are procedures for removing from the packaging line and appropriately storing unused 

packaging and labels after a production run is complete, including ensuring that product 

labels/packages are switched appropriately at product changeover.

11.7.2 Monitoring and Verification for Label Controls

As with an allergen cross-contact control, you have flexibility to apply preventive control 

management components as appropriate to ensure the effectiveness of the preventive controls, 

and the nature of a label control is such that in some cases a preventive control management 

component for a label control could be classified as either a monitoring activity or a verification

activity, as long as you comply with requirements applicable to monitoring or verification. For 

example, checking a product label/package that you receive from a supplier against your food 

allergen label specification generally could be classified as either a monitoring activity or a 

verification activity. Thus, if you conduct such a check you could classify this check as 

“monitoring” the content of the product label, or you could classify this check as “verifying” the 

content of the product label. 

In other cases, a preventive control management activity for a label control would commonly be 

considered a monitoring activity rather than as a verification activity. For example, checking that 

the correct label/package is being applied/used during a production run generally is classified as 

a monitoring activity. In some cases a preventive control management activity for a label control 

would commonly be considered a verification activity rather than a monitoring activity. For 

example, part 117 classifies review of records as a verification activity (see 21 CFR 

117.165(a)(4)).

You have flexibility to determine what monitoring/verification activities, and how many

monitoring/verification activities, are appropriate for your operation to ensure the effectiveness 

of the preventive control. (See 21 CFR 117.140(a).). For example, in some cases you could 

determine to monitor that labels/packages brought to the staging area are the correct 

labels/packages for the product by visually checking the labels/packages, but not verify this 

label control (such as by using a barcode scanner to confirm that the correct label/package is 

applied to/used for the correct product). In addition, you could classify visual checks and use of 

a barcode scanner to be either monitoring or verification as long as you comply with 

requirements applicable to monitoring or verification. However, regardless of whether you 

classify a specific activity as monitoring or as verification, the nature and number of activities

you conduct must be adequate to ensure the effectiveness of the preventive control. (See 21 

CFR 117.140(a)). In addition, you must verify the results of that activity by reviewing applicable 

records. (See 21 CFR 117.165(a)(4).)

In this section of this chapter, we provide a combined list of examples of monitoring and 

verification activities without classifying the activities as either monitoring or verification. See

sections 11.12.3.2 and 11.13.3.2 for examples of how manufacturers that establish and 

implement label controls could classify specific activities as monitoring or verification.
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11.7.2.1 What to monitor or verify for a label control

11.7.2.1.1 Label content

To monitor or verify the content of the product label, we recommend that you confirm that a 

product label/package that you receive from a label supplier, or that you generate yourself:

• Satisfies the food allergen label specification that you developed for the product; and

• Is the correct label/package for a particular product with a particular ingredient specification 

(i.e., recipe or formulation).

11.7.2.1.2 Label management

To monitor or verify the management of product labels/packages, we recommend that you 

confirm that the correct label/package is applied to/used for the correct product. 

11.7.2.2 How to monitor or verify a label control

11.7.2.2.1 Label content

To monitor or verify the content of the product label/package, we recommend that you put a 

hold on product labels/packages that you receive, or the product labels that you generate 

yourself, until you compare them to your food allergen label specification by manually inspecting

product labels/packages to:

• Reconcile allergen-related label information on the product label (i.e., declaration of 

ingredients and name of the food source of allergenic ingredients and allergenic 

components of ingredients) with the food allergen label specification; and

• Determine whether other specifications (e.g., for color coding related to allergen control) are

satisfied.

11.7.2.2.2 Label management

To monitor or verify the management of product labels/packages, we recommend that you:

• Visually check that labels/packages brought to the staging area are the correct 

labels/packages for the product; and

• Use a barcode scanner to confirm that the correct label/package is applied to/used for the 

correct product when doing so is practical for your operation. Alternatively, you could 

manually confirm that the correct label/package is applied to/used for the correct product. 
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11.7.2.3 How often to monitor or verify a label control

11.7.2.3.1 Label content

We recommend that you monitor or verify the content of the product label before you use it for 

production by comparing the product labels/packages to your food allergen label specification at 

one or more of the following stages24: 

• Upon receipt of the label (or, for labels that you generate yourself, soon after you print the 

labels); 

• Before new batches of labels are released for use during production; or

• Immediately prior to production.

11.7.2.3.2 Label management

• We recommend that you visually check that labels/packages brought to the staging area (or 

directly to the processing line) are the correct labels/packages for the product during staging 

or immediately prior to production.

• When confirming that the correct label is applied to/used for the correct product, we 

recommend that you:

o Do so at the beginning of production, and each time that new labels/packages are 

brought to the production line, if you monitor or verify by manual inspection; or

o Monitor or verify continuously during production if the barcode scanner scans 

continuously, or at regular intervals if you manually operate the barcode scanner or 

manually confirm that the correct label/package is applied to/used for the correct product

(e.g., 1-, 2-, or 4-hour intervals).

11.7.2.4 Who monitors or verifies a label control

11.7.2.4.1 Label content

• The personnel who compare the product labels/packages to your food allergen label 

specification depend, in part, on when the confirmation takes place (e.g., upon 

receipt/printing; before new batches of labels are released for production; or immediately 

prior to production) (see section 11.7.2.3). Note that individuals who manufacture, process, 

pack, or hold food must be qualified to perform their assigned duties (21 CFR 117.4).

Immediately below, we list some examples of personnel positions that could conduct 

monitoring/verification activities; this list is not exhaustive. Although a supervisor could be 

appropriate (e.g., for a large operation), non-supervisory personnel with appropriate 

qualifications could also be appropriate. In addition, when we identify a “team” we do so for 

illustrative purposes rather than to recommend that you organize your personnel into such 

teams.

24 The action of confirming the content of the product label before you use it for production is more 

important than the timeframe of when you confirm the content of the product label. We note that

confirming the content of the product label upon receipt/printing can save you down time if you discover a 

problem before you are ready to use the labels in a production run.
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o Personnel who have responsibility for operations such as receiving, quality assurance, 

or regulatory affairs (e.g., for label compliance) could confirm the food allergen 

specification of the product label/package upon receipt from the supplier of the 

labels/packages. 

o Personnel such as the supervisor (or other qualified representative) of the Label 

Production Team, and personnel with responsibility for operations such as quality 

assurance or regulatory affairs (e.g., for label compliance) could confirm the food 

allergen specification of a product label that you generate yourself after printing 

production labels. 

o Personnel such as the supervisor (or other qualified representative) of the Label 

Production Team, or personnel with responsibility for operations such as quality 

assurance or regulatory affairs (e.g., for label compliance) could confirm the food 

allergen specification of the product label/package before new batches of labels are 

released for production. 

o Personnel such as the line operator could confirm the food allergen specification of the 

product label/package immediately prior to production. 

11.7.2.4.2 Label management 

• Personnel such as the line operator or supervisor, the production supervisor, and quality 

control personnel could confirm the check of the product labels/packages. 

• When confirming that the correct label is applied to/used for the correct product: 

o Personnel such as the line operator or supervisor, the production supervisor, and quality 

control personnel could conduct the monitoring or verification activity if you confirm by 

manual inspection or manual operation of a barcode scanner. 

o The scanner does the monitoring or verification activity if you confirm using a continuous

barcode scanner. 

11.7.3 Corrective Actions/Corrections for Label Controls

When a label control has not been properly implemented, you must implement corrections or 

take corrective actions in accordance with your corrective action procedures. (See 21 CFR 

117.150.) 

• Examples of when a correction can suffice are:

o Label content. Determining that the content of a product label/package is incorrect with 

respect to the allergen labeling requirements of the FD&C Act before using the 

label/package in production. If you correct the label before using it such that no food is 

affected, you could consider the problem to be a minor and isolated problem that does 

not directly impact product safety as specified by 21 CFR 117.150(c)(2). 

o Label management. An observation that the incorrect label/package was brought to the 

staging area. If you correct the problem by returning the incorrect label/package to 

storage so that it is not used to label/package food, and bringing the correct 

label/package to the staging area before production begins, you could consider that the 

problem is a minor problem that does not directly impact product safety as specified in 

21 CFR 117.150(c)(2), unless the problem is a recurring problem. The provisions of 21 
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CFR 117.150(c)(2) for corrections apply to isolated problems rather than recurring 

problems; in contrast, corrective actions are appropriate for problems that affect food 

safety or recur frequently and include identifying the cause of the problem and taking

steps to prevent the problem from happening in the future. 

• Examples of when a corrective action is warranted are:

o Label content. Determining that the content of a product label/package is incorrect with 

respect to the allergen labeling requirements of the FD&C Act after using the 

label/package in production. Because an incorrect label with respect to the allergen 

labeling requirements of the FD&C Act would misbrand the food under section 403(w) of 

the FD&C Act, the incorrect label content is not a minor problem as specified by 21 CFR 

117.150(c)(2). In such a situation, corrective actions would include:

 Identifying the problem (e.g., by asking the label supplier (or, for labels generated inhouse by talking to the person who generated the labels) to determine what went 

wrong); 

 Correcting the problem and reducing the likelihood that the problem will recur (e.g., 

by reviewing the supplier’s corrective actions and by making appropriate changes to 

your Label Content Procedures25); and 

 Evaluating the product for safety in the same manner as for a corrective action for a 

problem with the label management control. (See corrective actions for a problem 

with label management immediately below.)

o Label management. Determining that an incorrect label (with respect to the allergen 

labeling requirements of the FD&C Act) was applied to a food product (e.g., a label for a 

different product, with a different food allergen profile, was applied), or that food was 

placed in an incorrect package (in that the product label on the package does not satisfy 

the allergen labeling requirements of the FD&C Act), during a production run. Because 

an incorrect label would misbrand the food under section 403(w) of the FD&C Act, the 

problem would not be a minor problem as specified in 21 CFR 117 117.150(c)(2). In 

such a situation, corrective actions would include:

 Identifying the problem (e.g., by determining whether the incorrect label was brought 

to the production line); 

 Correcting the problem and reducing the likelihood that the problem will recur (e.g., 

by revising the procedure for checking that the correct label/package has been 

brought to the staging area, or re-training personnel); 

 Ensuring that any food with an incorrect label does not enter commerce – e.g., by reworking the food product, re-labeling the food product, re-packaging the food product

with a correct label, diverting the food product to animal food (usually for animals 

other than pets)26, or destroying the food product; and

 Recalling food with an incorrect label if the food has already entered commerce. 

25 If you fail to identify an incorrect label until after it is used in production, you should also review your 

Label Management Procedures. 26 FDA is developing guidance on the use of human food by-products in animal food, including diversion 

of human food products to animal food use. In 2016, FDA issued for public comment a draft guidance for 

industry entitled “Human Food By-Products For Use As Animal Food” (see Table 11-7 and 81 FR 58521, 

August 25, 2016). In determining whether it is appropriate to divert a food product to animal food use, we 

recommend that you consult the final guidance on this subject when it becomes available.
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11.7.4 Reanalysis for Label Controls

As discussed in section 11.5.5, part 117 includes requirements for you to conduct a reanalysis 

of the food safety plan as a whole, or the applicable portion of the food safety plan, whenever 

you find that a preventive control, combination of preventive controls, or the food safety plan as 

a whole is ineffective. (See 21 CFR 117.170(b)(4).) Reanalysis of your label controls is 

appropriate if, for example, you have recurring problems with your label content controls or label 

management controls.

11.7.5 Records Documenting the Label Controls and Applicable Preventive 

Control Management Components

Your Label Content Procedure and Label Management Procedure are preventive controls and, 

thus, you must have a record of those procedures. (See 21 CFR 117.135(b) and 21 CFR 

117.126(b)(2).)

Records of monitoring and verification activities may be created manually or automatically (e.g., 

if a computer record is generated automatically when you use a barcode scanner). For manual 

records, we recommend you use standardized forms and checklists, as appropriate to the 

activity being monitored or verified, because such forms can help ensure that the activities are 

conducted in a consistent manner.

As noted in section 11.5.6, exception records for monitoring may be adequate in some 

circumstances. (See 21 CFR 117.145(c)(2)(ii).) For example, if you use an automated barcode 

scanner to monitor that the correct label is applied to/used for the correct product, it may be 

adequate to generate exception records when the scanner detects that the wrong label is 

applied to the product. Alternatively, a checklist that you include in a production record could 

document that you conducted the monitoring, with exception records for any observed

nonconformance. For example, you could use a checklist to document that you monitor product 

labels to reconcile allergen-related label information on the product label with the ingredient 

specifications (i.e., the recipe or formulation) of the food product and generate exception 

records for those instances when you determine that the label content was incorrect with 

respect to the label specification.

You must document all corrective actions and, as appropriate, corrections. (See 21 CFR 

117.150(d).) If an incorrect label is applied to a product, you would document the corrective 

actions you take. An example of when it could be appropriate to document corrections is when 

you notify a supplier that a “proof” of a product label does not match the food allergen label 

specification, because review of such records could demonstrate whether a particular supplier 

has consistent problems in satisfying the food allergen label specification during label 

development.

All verification activities must be documented. (See 21 CFR 117.155(b).) One way to document

your record review is for your PCQI (or designee) to sign or initial, and date, the primary 

monitoring, corrective action, and verification records.
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11.8 Supply-Chain Program

11.8.1 Regulatory Framework for the Supply-Chain Program

A receiving facility must establish and implement a risk-based supply-chain program for those 

raw materials and other ingredients for which the receiving facility has identified a hazard 

requiring a supply-chain-applied control. (See 21 CFR 117.405(a)(1).) A supply-chain program 

must include using approved suppliers and conducting appropriate supplier verification 

activities.27 (See 21 CFR 117.410.) When a hazard that requires a supply-chain applied control 

is a SAHCODH hazard (i.e., a hazard for which there is a reasonable probability that exposure 

to the hazard will result in serious adverse health consequences or death to humans (e.g., when 

a recall of a violative product is designated as “Class 1” under 21 CFR 7.3(m)(1))), an audit is 

required as a supplier verification activity in most circumstances, before using the raw material 

or other ingredient from the supplier and at least annually thereafter. (See 21 CFR 

117.430(b)(1).)28 Reactions to a food allergen can be severe (e.g., anaphylaxis that can lead to

cardiovascular collapse and death) (Taylor and Hefle, 2001; Boyce et al., 2010) and, thus, there 

is a reasonable probability that exposure to a food allergen hazard will result in serious adverse 

health consequences or death to humans. Therefore, in most circumstances29, a food allergen 

hazard will be a SAHCODH hazard and generally an annual audit will be required as a supplier 

verification activity. However, see the discussion in section 11.8.3.2 regarding circumstances 

when it might be appropriate for your PCQI to use the flexibility provided in 21 CFR 

117.430(b)(2) to make a written determination that other verification activities and/or less 

frequent onsite auditing of the supplier provide adequate assurance that the hazards are 

controlled.

In some cases, a supplier of a raw material or other ingredient that is, or contains, a food 

allergen would also be controlling other hazards that require a supply-chain applied control. For 

example, if your supplier dry roasts tree nuts, including almonds that you would use to make 

trail mix, your supplier would be controlling the biological hazard Salmonella in the almonds. In 

such a circumstance, your supply-chain program would address Salmonella hazards as well as 

food allergen hazards. See part 117, subpart G for the complete requirements for a supplychain program and Chapter 15 for comprehensive guidance on how to comply with the 

requirements of part 117, subpart G. 

11.8.2 When to Establish and Implement a Supply-chain Program as a 

Preventive Control for a Food Allergen Hazard 

We recommend that you:

• Discuss the food allergen profile of a potential supplier’s products during your initial 

consultation with the potential supplier (e.g., during a telephone conversation, or as part of 

any questionnaire that you use for initial consultations with potential suppliers); and 

27 See Table 11-8 for our website “Firm/Supplier Evaluation Resources for FSMA Rules.”

28 The requirement for an annual onsite audit does not apply if there is a written determination by the 

PCQI that other verification activities and/or less frequent onsite auditing of the supplier provide adequate 

assurance that the hazards are controlled. (See 21 CFR 117.430(b)(2).)

29 Undeclared major food allergens that have been known to cause fatal reactions are generally classified 

as Class I recalls. FDA considers each situation on a case-by-case basis when determining the 

appropriate recall classification.
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• Establish and implement a supply-chain program for the control of food allergen hazards if it 

is reasonably foreseeable that the food allergen profile(s) of food products produced by a 

potential supplier could lead to allergen cross-contact in raw materials or other ingredients 

that you would receive from that supplier. 

The nature and extent of your supply-chain program would depend on the food allergen profile 

of the potential supplier’s products (e.g., the severity of the hazard if allergen cross-contact were 

to occur, and whether the allergen cross-contact is likely to be extensive (such as when an

allergen present due to cross-contact could be distributed homogeneously in the product30) or 

limited (such as when an allergen present due to cross-contact is more likely to be distributed 

non-homogeneously31)) and the food allergen program in place at the supplier (including CGMP 

measures and preventive controls for allergen cross-contact). See the discussion in section

11.8.3 of examples of supplier approval and verification activities in supply-chain programs that 

depend on such factors. 

In general, we see no reason for you to establish and implement a supply-chain program for the 

control of food allergen hazards if:

• You will receive a raw material or other ingredient from a supplier that does not 

manufacture, process, or pack any food allergens; or

• You will receive a raw material or other ingredient that is (or contains) a food allergen from a 

supplier, and that food allergen is the only food allergen that the supplier 

manufactures/processes. For example, if the supplier is an almond handler that 

manufactures/processes almonds, but does not manufacture/process other tree nuts, or 

other foods (such as milk products, soy products, or peanut butter) that are, or contain, a 

food allergen, there would be no need to evaluate whether the supplier has appropriate 

procedures in place to prevent allergen cross-contact between foods with different food 

allergen profiles.

11.8.3 Supplier Approval and Supplier Verification Activities in a SupplyChain Program for the Control of Food Allergen Hazards

11.8.3.1 Evaluating whether a potential supplier provides allergen 

advisory statements for raw materials or other ingredients that you would 

receive from the supplier before approving the supplier

As discussed in section 11.9.3, we recommend that your supplier approval and verification 

activities include an evaluation of whether a potential supplier provides allergen advisory 

statements for raw materials and other ingredients that you would receive from the potential 

supplier. When a potential supplier would provide an allergen advisory statement on the 

applicable raw materials or other ingredients, we recommend that you discuss the reasons for 

the allergen advisory statement with the potential supplier before approving the supplier. You 

should approve a supplier that provides allergen advisory statements for its products only if you 

30 Liquid milk and liquid soy (such as in a soy beverage) are examples of allergens that could be 

distributed homogeneously. 

31 Pieces of tree nuts and peanuts are examples of allergens likely to be distributed non-homogeneously.
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determine that such statements are not being used in lieu of adherence to CGMPs or in lieu of 

adherence to the requirements for allergen cross-contact controls.

11.8.3.2 Determining the appropriate supplier approval and verification 

activities

As noted in section 11.8.1, most food allergen hazards are SAHCODH hazards and, thus, an 

annual audit will be the appropriate supplier approval and verification activity in most 

circumstances when you establish and implement a supply-chain program for a food allergen 

hazard. (See 21 CFR 117.430(b)). However, the PCHF requirements provide flexibility for your 

PCQI to provide a written determination that other verification activities and/or less frequent

onsite auditing of the supplier provide adequate assurance that the hazards are controlled. (See 

21 CFR 117.430(b)(2).) See Table 11-4 for some examples of appropriate supplier approval and 

verification activities in various circumstances. 

If your supplier provides allergen advisory statements for the raw materials or other ingredients 

that you receive from the supplier, product testing for the food source that is the subject of the 

allergen advisory statements can provide you with information about the frequency with which 

the applicable food allergen is present in the raw materials or other ingredients that you receive 

and, when the food allergen is present, about the levels of the applicable food allergen. If your 

PCQI will use the results of product testing as part of a determination of whether to carry an 

allergen advisory statement forward to your own food products, we recommend that you 

conduct such testing on multiple lots of the applicable raw material or other ingredient as part of 

your supplier approval process, and then periodically as an ongoing supplier verification activity 

to confirm the PCQI’s determination about whether to carry a supplier’s allergen advisory 

statement forward to your own food products. In developing your sampling plan for testing an 

individual lot, you should consider factors such as whether the food being sampled is 

homogeneous or non-homogeneous and whether a food allergen that is present due to allergen 

cross-contact is likely to be distributed homogeneously or non-homogeneously. 

If your supplier does not provide allergen advisory statements for the raw materials or other 

ingredients that you receive from the supplier, but the information you obtain, through your 

supply chain program, about your supplier’s food allergen program suggests that the potential 

for allergen cross-contact in raw materials or other ingredients obtained from that supplier is 

moderate or high, then periodic testing of the applicable raw material or other ingredient is an 

example of an ongoing supplier verification activity to verify that food from a supplier producing 

foods with different food allergen profiles has been protected from allergen cross-contact. Due 

to limitations in product testing, testing that you conduct as a supplier approval or verification 

activity should be in addition to other supplier approval and verification activities rather than the 

sole supplier approval and verification activity. You could conduct this testing yourself or request 

that your supplier have such testing conducted and provide you with a Certificate of Analysis 

(COA). The frequency of such testing could vary with the potential that the ingredient would not 

be protected from allergen cross-contact. For example, if a supplier that processes food 

products with different food allergen profiles on the same processing line combines scheduling, 

allergen cleaning procedures, and frequent verification testing in its food safety plan, your PCQI 

could determine that annual testing is appropriate. However, if a supplier that processes food 

products with different food allergen profiles on the same processing line does not do 

verification testing, more frequent testing (such as monthly or quarterly) could be appropriate. 

As discussed in section 11.3, FDA has not established a maximum amount of food allergen that 

may be present in labeled food products without need for declaration. However, FDA recognizes 
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that published data on population threshold dose responses to various food allergens are 

becoming increasingly available. These published data raise the possibility that some low-level 

exposures to certain food allergens, and the presence of certain allergen-derived ingredients, 

may not cause allergic reactions in most consumers who have that food allergy. Because food 

manufacturers/processors could evaluate such data in light of their specific products, such as 

through risk assessments or other scientifically valid scientific assessments, in making decisions 

on appropriate food allergen controls, where Table 11-4 mentions the results of testing we are 

referring merely to the detection of unintended allergen presence and not the level of the 

unintended food allergen. As discussed in sections 11.8.4 and 11.9.2, your PCQI has the 

responsibility to determine the appropriate approach to the potential presence in your food 

product of a food allergen from a food source that is not already an ingredient in that food 

product. 
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Table 11-4 Examples of Supplier Approval Activities and Ongoing Supplier Verification Activities

Ingredient Potential 

Unintended 

Allergen 

Presence Due 

to Allergen 

Cross-Contact 

at the Supplier

Food Allergen Program at the Supplier Potential for Allergen 

Cross-Contact at the 

Supplier and Supplier’s 

Decision Regarding 

Allergen Advisory 

Statements

Examples of Supplier 

Approval Activities

Examples of Ongoing 

Supplier Verification 

Activities

Vegan caramel 

chips that do not 

have any 

allergenic 

ingredients

Milk The supplier uses separate processing lines for vegan caramel

chips and caramel (or other) chips that contain milk. 

Low, because the supplier 

uses different processing 

lines for vegan caramel

chips and caramel (and 

other) chips that contain 

milk. Therefore, the 

supplier does not use 

allergen advisory

statements. 

- Questionnaire about 

food allergen control 

practices

- Search FDA’s 

“Firm/Supplier Evaluation 

Resources” web page

(see Table 11-8)

- Onsite audit 

- Annual Certificate of 

Conformance that the supplier 

continues to use separate 

processing lines for vegan 

caramel chips and caramel 

(and other) chips that contain 

milk. 

- Supplier audit every 3 years.

Vegan caramel

chips that do not 

have any 

allergenic 

ingredients

Milk - The supplier uses the same processing line for vegan 

caramel chips and caramel (and other) chips that contain milk. 

- Supplier’s allergen cross-contact controls and verification 

testing:

- The supplier schedules production of vegan caramel 

chips before production of caramel (and other) chips that 

contain milk.

- Before production of vegan caramel chips, the supplier’s 

allergen cleaning procedures include scrape-down of 

accessible surfaces and push-through (e.g., in piping) 

with vegan caramel, with the push-through material used 

as re-work in the production of caramel products that 

contain milk. 

- During development of the food safety plan, verification 

testing of vegan caramel chips consistently is negative 

whenever verification testing of FCSs of the chip 

depositor is negative.

- During production, the supplier routinely verifies the 

allergen cleaning by testing FCSs of the chip depositor 

for the presence of milk allergen, with repeat cleaning if 

necessary. 

Moderate, because the 

supplier uses the same 

processing line for vegan 

caramel chips and caramel 

(and other) chips that 

contain milk. However, the 

supplier combines 

scheduling, allergen 

cleaning procedures, 

verification testing, and 

repeat cleaning in its food 

safety plan. The supplier 

does not use advisory 

labeling because the 

verification testing during 

development of its food 

safety plan demonstrates 

that vegan caramel chips 

do not contain milk allergen 

whenever verification 

testing of the chip depositor 

is negative, and the 

supplier routinely verifies 

the cleaning by testing the 

chip depositor, with repeat 

cleaning as necessary.

- Questionnaire about 

food allergen control 

practices

- Search FDA’s 

“Firm/Supplier Evaluation

Resources” web page

(see Table 11-8)

- Onsite audit

- Test several shipments 

of vegan caramel chips

- Annual onsite audit

- Periodic testing of shipments 

of vegan caramel chips (e.g., 

quarterly or every 5th lot) 
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Ingredient Potential 

Unintended 

Allergen 

Presence Due 

to Allergen 

Cross-Contact 

at the Supplier

Food Allergen Program at the Supplier Potential for Allergen 

Cross-Contact at the 

Supplier and Supplier’s 

Decision Regarding 

Allergen Advisory 

Statements

Examples of Supplier 

Approval Activities

Examples of Ongoing 

Supplier Verification 

Activities

Vegan caramel

chips that do not 

have any 

allergenic 

ingredients

Milk - The supplier uses the same processing line for vegan 

caramel chips and caramel (and other) chips that contain milk. 

- Supplier’s allergen cross-contact controls and verification 

testing:

- The supplier schedules production of vegan caramel 

chips before production of caramel (and other) chips that 

contain milk.

- Before production of vegan caramel chips, the supplier’s 

allergen cleaning procedures include scrape-down of 

accessible surfaces and push-through (e.g., in piping) 

with vegan caramel, with the push-through material used 

as re-work in the production of caramel products that 

contain milk.

- During development of the food safety plan, verification 

testing of vegan caramel chips periodically is positive.

- The supplier samples and tests every lot for milk allergen 

and discards or reworks any lots of vegan caramel chips 

that contain milk into caramel products that contain milk.

- The supplier provides customers with a COA 

documenting negative test results for every lot. 

Moderate, because the 

supplier uses the same 

processing line for vegan 

caramel chips and caramel 

(and other) chips that 

contain milk. However, the 

supplier combines 

scheduling, allergen 

cleaning procedures, and 

verification testing of every 

lot in its food safety plan. 

The supplier does not use 

allergen advisory 

statements because only 

those lots of vegan caramel 

chips that are negative for

milk allergen are 

distributed. 

- Questionnaire about 

food allergen control 

practices

- Search FDA’s 

“Firm/Supplier Evaluation 

Resources” web page

(see Table 11-8)

- Onsite audit

- Test several shipments 

of vegan caramel chips

for milk

- Annual onsite audit

- Annual sampling and testing 

(as verification of the supplier’s 

sampling and testing of every 

lot)
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Ingredient Potential 

Unintended 

Allergen 

Presence Due 

to Allergen 

Cross-Contact 

at the Supplier

Food Allergen Program at the Supplier Potential for Allergen 

Cross-Contact at the 

Supplier and Supplier’s 

Decision Regarding 

Allergen Advisory 

Statements

Examples of Supplier 

Approval Activities

Examples of Ongoing 

Supplier Verification 

Activities

Vegan caramel

chips that do not 

have any 

allergenic 

ingredients

Milk - The supplier uses the same processing line for vegan 

caramel chips and caramel (and other) chips that contain milk. 

- Supplier’s allergen cross-contact controls and verification 

testing:

- During development of the food safety plan, the supplier 

assessed multiple cleaning practices for efficacy in 

preventing allergen cross-contact, but regardless of 

which cleaning practice was used verification test results 

were periodically positive for unintended milk presence 

on FCSs on the chip depositor and in vegan caramel

chips. 

- The supplier concludes that its verification testing during 

development of the food safety plan demonstrates that 

its cleaning is not always able to protect the vegan 

caramel chips from allergen cross-contact. 

- The supplier’s PCQI provides a written justification, in the 

supplier’s food safety plan, for why allergen crosscontact controls are not always able to ensure protection 

of food from allergen cross-contact; 

- The supplier’s labeling for the applicable food product(s) 

includes allergen advisory statements that disclose the 

possible unintended allergen presence in the food; and, 

- Because the supplier provides allergen advisory 

statements, the supplier does not routinely do 

verification testing of either the FCSs on the chip 

depositor or the vegan caramel chips.

High. The supplier uses 

allergen advisory 

statements because it uses 

the same processing line 

for vegan caramel chips 

and non-vegan caramel 

(and other) chips that 

contain milk, and its 

verification testing during 

development of the food 

safety plan demonstrates 

that its cleaning is not 

always able to protect the 

vegan caramel chips from 

allergen cross-contact. 

- Questionnaire about 

food allergen control 

practices

- Search FDA’s 

“Firm/Supplier Evaluation 

Resources” web page

(see Table 11-8)

- Onsite audit

- Test multiple lots for the 

frequency and level of 

detectable milk as part of 

the PCQI’s determination 

of whether to carry an 

allergen advisory 

statement forward 

- Annual onsite audit

- If an allergen advisory 

statement is carried forward,

annual sampling and testing of 

vegan caramel chips for the 

frequency and level of 

detectable milk to confirm the 

results obtained during supplier 

approval and determine 

whether to conduct reanalysis: 

- Of the PCQI’s 

determination to carry 

forward an allergen 

advisory statement, and

- To re-evaluate the 

supplier. 

- If an allergen advisory 

statement is not carried 

forward, monthly sampling and 

testing of vegan caramel chips 

for the frequency and level of 

detectable milk to confirm the 

results obtained during supplier 

approval and determine 

whether to conduct reanalysis: 

- Of the PCQI’s 

determination to not carry 

forward an allergen 

advisory statement; and

- To-re-evaluate the 

supplier. 
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Ingredient Potential 

Unintended 

Allergen 

Presence Due 

to Allergen 

Cross-Contact 

at the Supplier

Food Allergen Program at the Supplier Potential for Allergen 

Cross-Contact at the 

Supplier and Supplier’s 

Decision Regarding 

Allergen Advisory 

Statements

Examples of Supplier 

Approval Activities

Examples of Ongoing 

Supplier Verification 

Activities

Almond-based 

beverage

Soy - The supplier uses the same processing line for almondbased beverages and soy-based beverages.

- Supplier’s allergen cross-contact controls and verification 

testing:

- The supplier develops allergen cleaning procedures for 

use when changing from one beverage type to the other.

- During development of the food safety plan, verification 

testing of FCSs on the processing line and in the 

almond-based beverage is consistently negative for the 

presence of soy allergen. 

- During routine production, the supplier monitors the 

cleaning procedures and conducts sampling and 

analytical testing for residues of soy as verification, at 

least quarterly or more frequently as requested by the 

customer. 

Moderate, because the 

supplier uses the same 

processing line for almondbased and soy-based 

beverages. However, the 

supplier does not use 

allergen advisory

statements due to the liquid 

nature of the food products 

and consistently negative 

test results from verification 

testing of its cleaning 

procedures during 

development of the food 

safety plan.

- Questionnaire about 

food allergen control 

practices

- Search FDA’s “Supplier 

Evaluation Resources” 

web page (see Table 11-

8)

- Onsite audit

- Test several shipments 

for soy

- Annual onsite audit

- Receive COAs with every 

shipment for the first 6 months

- Receive quarterly COAs after 

the first 6 months

- Annual sampling and testing 

(as verification of the supplier’s 

quarterly sampling and testing)

Dry-roasted 

almonds

Dry-roasted 

peanuts

- Supplier’s CGMP measures for separation in space:

- The supplier has separate storage areas in separate 

buildings for almonds and peanuts.

- The supplier has separate processing lines in separate 

buildings for almonds and peanuts. 

Low, because the supplier 

stores and processes 

almonds and peanuts in 

separate buildings. 

Therefore, the supplier 

does not use allergen 

advisory statements. 

- Questionnaire about 

food allergen control 

practices

- Search FDA’s “Supplier 

Evaluation Resources” 

web page (see Table 11-

8)

- Onsite audit

- Annual Certificate of 

Conformance that the supplier 

continues to use separate 

buildings for storing and 

processing almonds and 

peanuts. 

- Supplier audit every three 

years.

Dry-roasted 

almonds

Dry-roasted 

peanuts

- Supplier’s CGMP measures for separation in space:

- The supplier stores almonds and peanuts in separate 

rooms of the same building. 

- The supplier has separate processing lines in separate 

rooms of the same building for almonds and peanuts.

- The supplier has dedicated apparel, portable equipment, 

utensils, and tools for almonds and peanuts. 

- Supplier’s allergen cross-contact controls, subject to 

monitoring:

- Almonds and peanuts are color-coded upon receipt. 

- Apparel, portable equipment, utensils, and tools are 

color-coded or tagged.

- Traffic patterns restrict movement of personnel, portable 

equipment, utensils, and tools.

Low, because the supplier 

stores and processes 

almonds and peanuts in 

separate rooms, and has 

allergen cross-contact 

controls for ingredients, 

apparel, portable 

equipment, utensils, and 

tools. Therefore, the 

supplier does not use 

allergen advisory

statements. 

- Questionnaire about 

food allergen control 

practices

- Search FDA’s “Supplier 

Evaluation Resources” 

web page (see Table 11-

8)

- Onsite audit

- Annual Certificate of 

Conformance that the supplier 

continues to use separate 

rooms for storing and 

processing almonds and 

peanuts and continues to 

implement its allergen crosscontact controls for ingredients, 

apparel, portable equipment, 

utensils and tools

- Supplier audit every other 

year.
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 44 

Ingredient Potential 

Unintended 

Allergen 

Presence Due 

to Allergen 

Cross-Contact 

at the Supplier

Food Allergen Program at the Supplier Potential for Allergen 

Cross-Contact at the 

Supplier and Supplier’s 

Decision Regarding 

Allergen Advisory 

Statements

Examples of Supplier 

Approval Activities

Examples of Ongoing 

Supplier Verification 

Activities

Dry-roasted 

almonds

Dry-roasted 

peanuts

- Supplier’s CGMP measures for separation in space and time:

- The supplier stores shelled almonds and shelled peanuts 

in covered containers in separate storage areas, 

separated by plastic curtains, in the same storage room.

- The supplier has separate processing lines, separated by 

plastic curtains, in the same room, for almonds and 

peanuts. 

- The supplier schedules production of roasted almonds 

and roasted peanuts at different times.

- Supplier’s allergen cross-contact controls and verification

testing: 

- Almonds and peanuts are color-coded upon receipt to 

facilitate storing in the correct area and ingredient 

identification when bringing shelled almonds and shelled 

peanuts to the production line. 

- Apparel, portable equipment, utensils, and tools are 

dedicated and color-coded or tagged for use with either 

almonds or peanuts. 

- Traffic patterns restrict movement of personnel, portable 

equipment, utensils, and tools.

- During the development of the food safety plan, conducts 

verification procedures by sampling and sorting almonds 

to look for peanuts, or by analytical testing for peanut 

residue, is consistently negative.

- During routine production, when the supplier does its 

quality control (QC) checks on samples of almonds for 

color and size, it also sorts the sample and looks for 

peanuts. 

Low, because the supplier 

has CGMP measures for 

separation in both space 

and time, has allergen 

cross-contact controls for 

ingredients, apparel, 

portable equipment, 

utensils, and tools, and 

during development of the 

food safety plan verification 

testing for peanuts and 

peanut residue is 

consistently negative. 

Therefore, the supplier 

does not use allergen 

advisory statements. 

- Questionnaire about 

food allergen control 

practices

- Search FDA’s “Supplier 

Evaluation Resources” 

web page (see Table 11-

8)

- Onsite audit

- Sample and sort 

almonds from several 

shipments to look for 

peanuts 

- Annual onsite audit

- Periodic (e.g., semi-annually

checking shipments of almonds

by sampling and sorting to look 

for peanuts
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Chapter 11 (Food Allergen Program) - Page 45 

Ingredient Potential 

Unintended 

Allergen 

Presence Due 

to Allergen 

Cross-Contact 

at the Supplier

Food Allergen Program at the Supplier Potential for Allergen 

Cross-Contact at the 

Supplier and Supplier’s 

Decision Regarding 

Allergen Advisory 

Statements

Examples of Supplier 

Approval Activities

Examples of Ongoing 

Supplier Verification 

Activities

Dry-roasted 

almonds

Dry-roasted 

cashews 

- The supplier uses the same production line for almonds and 

cashews.

- Supplier’s CGMP measures for separation in space: 

- Separate storage areas, in different rooms, for shelled 

almonds and shelled cashews.

- Supplier’s allergen cross-contact controls and verification 

testing:

- Almonds and cashews are color-coded upon receipt to 

facilitate storing in the correct area and ingredient 

identification when bringing shelled almonds and shelled 

cashews to the production line. 

- Apparel, portable equipment, utensils, and tools are 

dedicated and color-coded or tagged for either almonds 

or cashews. 

- The supplier consults with an expert in dry cleaning 

techniques to develop cleaning procedures for use when 

changing from one nut to the other.

- During development of the food safety plan, verification 

testing by sampling and sorting almonds to look for 

cashews, or by analytical testing for cashew residue, is 

rarely positive. 

- During routine production, the supplier monitors the 

cleaning procedure and conducts analytical tests of 

FCSs for cashew residue before beginning production of 

almonds, with repeat cleaning if necessary.

- During routine production, the supplier holds each lot 

until receiving the results of verification procedures

(sampling and sorting almonds to look for cashews) and 

analytical testing for cashew residue. The supplier

reworks any lots of almonds that contain cashews in a 

mixed nuts product. 

- The supplier provides a COA with the results of its 

verification testing for each shipment of almonds.

Moderate, because the 

supplier uses the same 

processing line for almonds 

and cashews. However, the 

supplier does not use 

allergen advisory

statements because the 

verification testing of its 

allergen cross-contact 

controls during 

development of its food 

safety plan demonstrates 

that the frequency of 

allergen cross-contact is 

low, it routinely monitors 

the cleaning during 

production, it follows “hold 

and test” procedures before 

distributing almonds, and it 

provides a COA with the 

results of verification 

testing for every lot of 

almonds. 

- Questionnaire about 

food allergen control 

practices

- Search FDA’s “Supplier 

Evaluation Resources” 

web page (see Table 11-

8)

- Onsite audit

- Sample and sort 

almonds from several 

shipments to look for 

cashews 

- Test several shipments 

for cashew residue

- Annual onsite audit

- Supplier COA for each 

shipment

- Periodic (e.g., semi-annually 

or every 6th lot) checking 

shipments of almonds by 

sampling and sorting to look for 

cashews and testing for 

cashew residue (as verification 

of the supplier’s sampling and 

testing of every lot)
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Chapter 11 (Food Allergen Program) - Page 46 

Ingredient Potential 

Unintended 

Allergen 

Presence Due 

to Allergen 

Cross-Contact 

at the Supplier

Food Allergen Program at the Supplier Potential for Allergen 

Cross-Contact at the 

Supplier and Supplier’s 

Decision Regarding 

Allergen Advisory 

Statements

Examples of Supplier 

Approval Activities

Examples of Ongoing 

Supplier Verification 

Activities

Dry-roasted 

almonds

Dry-roasted 

cashews 

- The supplier uses the same production line for almonds and 

cashews.

- Supplier’s CGMP measures for separation in space: 

- Separate storage areas, in the same room, for almonds 

and cashews.

- Supplier’s allergen cross-contact controls and verification

testing: 

- Almonds and cashews are color-coded upon receipt.

- Apparel, portable equipment, utensils, and tools are 

dedicated and color-coded or tagged for either almonds 

or cashews. 

- The supplier develops cleaning procedures for use when 

changing from one nut to the other.

- During development of the food safety plan, assessed

multiple cleaning practices for efficacy in preventing 

allergen cross-contact, but regardless of which cleaning 

practice was used verification testing by sampling and 

sorting almonds to look for cashews, or by analytical 

testing for cashew residue, is frequently positive. 

- The supplier concludes that its verification testing during 

development of the food safety plan demonstrates that 

its cleaning is not always able to protect the almonds 

from allergen cross-contact. 

- The supplier’s PCQI provides a written justification, in the 

supplier’s food safety plan, for why allergen crosscontact controls are not always able to ensure protection 

of food from allergen cross-contact. 

- The supplier’s labeling for the applicable food product(s) 

includes allergen advisory statements that disclose the 

possible unintended allergen presence in the food. 

 - Because the supplier provides allergen advisory 

labeling, the supplier does not routinely do verification 

testing of either the FCSs on the processing line or the 

almonds.

High. The supplier uses 

allergen advisory labeling 

because it uses the same 

production line for almonds 

and cashews and 

verification testing during 

development of the food

safety plan demonstrates 

that its cleaning is not 

always able to protect the 

almonds from allergen 

cross-contact. 

- Questionnaire about 

food allergen control 

practices

- Search FDA’s “Supplier 

Evaluation Resources” 

web page (see Table 11-

8)

- Onsite audit

- Sample and sort 

almonds from several 

shipments to look for 

cashews, and test several 

shipments for the 

presence of cashew

residue, as part of the 

PCQI’s determination of 

whether to carry the 

allergen advisory labeling 

forward 

- Annual onsite audit

- If allergen advisory labeling is 

carried forward, periodic 

checking shipments of almonds 

by sampling and sorting to 

confirm the results obtained 

during supplier approval

- If allergen advisory labeling is 

not carried forward, periodic 

checking shipments of almonds 

by sampling and sorting, and by 

testing for cashew residue, to 

confirm the results obtained 

during supplier approval and 

determine whether to conduct 

reanalysis:

- Of the PCQI’s 

determination to not carry 

forward allergen advisory 

labeling; and

- To-re-evaluate the 

supplier.

- Frequency of sampling and 

sorting (and, when applicable, 

analytical testing) varies 

depending on whether allergen 

advisory labeling is carried 

forward (e.g., monthly if 

allergen advisory labeling is not 

carried forward; semi-annually 

or every 6th lot if allergen 

advisory labeling is carried 

forward)
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11.8.3.3 Conducting an audit of a supplier when the hazard requiring a 

supply-chain applied control is a food allergen hazard

If you will conduct an onsite audit of a supplier, the onsite audit must be performed by a 

qualified auditor. (See 21 CFR 117.435 and the definition of a qualified auditor in 21 CFR 

117.3.) Specifically, the auditor that conducts audits to verify food allergen controls must have 

technical expertise obtained through education, training, or experience (or a combination of 

these) necessary to verify that a supplier is implementing measures adequate to control food 

allergens. 

When you conduct an audit for a supplier that is subject to the requirements of part 117,32

examples of activities to evaluate during the audit are33:

• Storage and handling practices for ingredients, WIP, rework, and finished goods;

• Methods used for physical separation, product containment, and product identification; 

• Production practices, including procedures for use of rework and WIP;

• Production scheduling; 

• Movement of raw materials and other ingredients that are, or contain, a food allergen;

• Use and segregation of specific utensils, implements, and tools;

• Procedures for the approval of labels and of packaging that contains pre-printed labels;

• Procedures for assuring that the correct label is applied to the correct food product; 

• Handling of obsolete labels/packaging;

• Sanitation procedures;

• Post-cleaning verification to ensure the absence of food allergens prior to processing a 

product with a different food allergen profile; 

• Procedures for monitoring food allergen controls; and

• Review of records, such as cleaning procedures, monitoring records, corrective action 

records, verification records, incoming inspection records of labels/packaging, training 

records, label/packaging approval records, and previous allergen audit reports and follow up 

reports to correct deficiencies, if any, found in those reports.

32 If your supplier is a facility that is not subject to the requirements for hazard analysis and risk-based 

preventive controls because it satisfies one of the criteria in 21 CFR 117.5 for an exemption, you would 

evaluate the supplier’s CGMP measures to prevent allergen cross-contact.

33 Adapted from “Managing Allergens in Food Processing Establishments” (GMA, 2009).
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11.8.4 Receiving a Raw Material or Other Ingredient From a Supplier That 

Provides Allergen Advisory Statements

As discussed in section 11.9.3, if you approve a supplier that provides an allergen advisory 

statement for a raw material or other ingredient, your supply-chain program should include a 

written determination by the PCQI of whether to carry an allergen advisory statement forward to 

any of your own products. For example:

• If your supplier provides an allergen advisory statement for vegan caramel chips (e.g., about 

the potential for unintended milk presence), and you will use the vegan caramel chips in a 

food product that contains an ingredient that is (or contains) milk (such as milk powder), your 

product label would already declare the food source “milk,” and there would be no need for 

an additional allergen advisory statement on your food product.

• If your supplier provides an allergen advisory statement for vegan caramel chips (e.g., about 

the potential for unintended milk presence), and you will use the vegan caramel chips in a 

food product that is not formulated to contain any other ingredient that is (or contains) milk, 

you should either:

o Carry such an allergen advisory statement forward to the product label on your food 

products, and specify in your Label Content Procedures for receiving the vegan caramel

chips that you treat the vegan caramel chips in the same manner as you treat other 

ingredients that are or contain a major food allergen;

34 or 

o Rely on a scientifically valid determination (which you include in your food safety plan) 

that the amount35 of milk allergen that may be present in labeled food products produced 

using that supplier’s ingredient is low enough such that the presence may not cause 

allergic reactions in most consumers who have that food allergy.

11.8.5 Corrective Actions and Corrections in the Event of Supplier Nonconformance

If you determine (e.g., through your supplier verification audit, periodic testing, or consumer 

complaints) that the supplier is not adequately controlling food allergen hazards, the 

requirements for a supply-chain program specify that you must take corrective action or 

corrections to ensure that raw materials or other ingredients from the supplier do not cause the 

food that you manufacture or process to be adulterated under section 402 of the FD&C Act.

(See 21 CFR 117.410(e) and 117.150.) 

Corrections could be appropriate if, for example, you find (through your ongoing supplier 

verification activities) that a supplier has an implementation issue with certain allergen controls, 

(e.g., an audit indicates that some of the procedures to control the movement of employees and 

mobile equipment to prevent cross contact have not been followed) but the observations 

indicate that cross-contact was unlikely. You could consider that non-compliance to be a minor 

problem that would not directly impact the safety of the food product that you purchase from that 

supplier. In such circumstances, corrections could include assessing the supplier’s explanation 

34 See the discussions in section 11.7.1.1.4 regarding Label Content Procedures for receipt of raw 

materials and other ingredients. 35 See discussion in section 11.3 regarding published data on population threshold dose responses to 

various food allergens. 
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of what went wrong and the steps that the supplier is taking to prevent the problem from 

recurring.

See 21 CFR 117.410(e) and 117.150 for the requirements applicable to corrective actions if you 

determine that the supplier is not controlling hazards that you have identified as requiring a food 

allergen control applied by the supplier. Corrective actions (rather than corrections) are 

appropriate when the problem with a supplier’s control of food allergen hazards impacts (or has 

the potential to impact) the safety of your product. For example, if your supplier recalls a 

powdered milk product due to unintended soy presence, and you had purchased that powdered 

milk product, you would follow the supplier’s instructions regarding powdered milk that you have 

not already used. However, the problem that led to the recall of the powdered milk product could 

directly impact the safety of food that you manufactured/processed before becoming aware of 

the recall as well as the safety of milk powder that you purchase from that supplier in the future. 

In such circumstances, corrective actions would include: 

• Identifying the problem (e.g., by determining why your supplier’s food allergen program

failed);

• Correcting the problem and reducing the likelihood that the problem will recur (e.g., by 

working with the supplier to ensure appropriate implementation of a food allergen program in 

the future or by changing suppliers); and

• Evaluating all affected food for safety (e.g., by evaluating the food you manufactured or 

processed for unintended allergen presence) and ensuring that any food with unintended

allergen presence does not enter commerce (or is removed from commerce if it has been 

shipped).

11.8.6 Reanalysis in the Event of Ongoing Supplier Nonconformance

As discussed in section 11.5.5, part 117 includes requirements for you to conduct a reanalysis 

of the food safety plan as a whole, or the applicable portion of the food safety plan, whenever 

you find that a preventive control, combination of preventive controls, or the food safety plan as 

a whole is ineffective. (See 21 CFR 117.170(b)(4).) Reanalysis of your supply chain program is 

appropriate if, for example:

• A supplier of raw materials or other ingredients that are at high risk for a food allergen 

hazard due to allergen cross-contact does not provide allergen advisory statements for 

those raw materials or other ingredients, but you repeatedly detect an unintended allergen 

presence during routine sampling and testing of those raw materials or other ingredients. 

Reanalysis to address the unintended allergen presence could include discussions with the 

supplier about the CGMP measures and allergen cross-contact controls used by the 

supplier to prevent allergen cross to help determine whether modifications are needed for 

your food safety plan.

• A supplier of raw materials or other ingredients that are at high risk for a food allergen 

hazard due to allergen cross-contact provides allergen advisory statements for those raw 

materials or other ingredients, and the detected levels of the unintended allergen presence

in raw materials or other ingredients during routine sampling and testing are sufficiently high 

to warrant discussion with the supplier about the CGMP measures and allergen crosscontact controls used by the supplier to prevent allergen cross-contact. 
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During reanalysis, your PCQI would determine whether to discontinue use of such suppliers. 

See also the discussions of reanalysis of allergen advisory labeling in section 11.9.5. In some 

circumstances, reanalysis of your supply-chain program could lead you to conclude that an 

allergen advisory statement for your product has become appropriate because you are not 

always able to assure, through your supply-chain controls, that the ingredient you receive will be 

protected from allergen cross-contact.

11.8.7 Records Documenting the Supply-Chain Program

See 21 CFR 117.475 for a list of records required to document a supply-chain program. See 

Chapter 15 for a comprehensive discussion of those records. 

11.8.8 Review of Records for the Supply-Chain Program

As specified in 21 CFR 117.475(b), you must review the records for your supply-chain program 

in accordance with §117.165(a)(4), which requires that a PCQI review (or oversee the review of)

your supply-chain records within a reasonable time after the records were created to ensure that 

the records are complete, the activities reflected in the records occurred in accordance with the 

food safety plan, the preventive controls are effective, and appropriate decisions were made 

about corrective actions. 

11.9 Allergen Advisory Statements

11.9.1 How the 1996 Food Allergen Notice Applies to CGMP Measures and 

PCHF Requirements

In the 1996 food allergen notice (see Table 11-8), we advised that, “because adhering to 

CGMPs is essential for effective reduction of adverse reactions by consumers, such 

precautionary labeling should not be used in lieu of adherence to CGMPs.” We also urged

manufacturers to “take all steps necessary to eliminate allergen cross-contamination and to 

ensure the absence of the identified food.”

When we issued the 1996 food allergen notice, your responsibility to prevent allergen crosscontact was solely addressed through CGMP requirements to prevent contamination and 

adulteration of food. In 2015 (80 FR 55908, September 17, 2015), we revised those CGMP 

requirements to more explicitly require that you use CGMP measures to prevent allergen crosscontact36. We also added new requirements for allergen cross-contact preventive controls to:

• Provide assurance that any food allergen hazards requiring a preventive control will be 

significantly minimized or prevented and the food manufactured, processed, packed, or held 

by your facility will not be adulterated under section 402 of the FD&C Act (21 CFR 

117.135(a)); and

• Ensure protection of food from allergen cross-contact (21 CFR 117.135(c)(2)(i)).

36 As noted in section 11.1, our more recent allergen labeling guidance also advises that labeling such as 

“may contain [allergen]” is not a substitute for adherence to either CGMPs or food allergen preventive 

controls.
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Consistent with the 1996 food allergen notice and our allergen labeling guidance:

• You should not use allergen advisory statements in lieu of adherence to the CGMP 

requirements to prevent allergen cross-contact; and

• You should not use allergen advisory statements in lieu of adherence to the requirements 

for allergen cross-contact controls. 

As discussed in section 11.1, this chapter does not broadly discuss other issues associated with 

allergen advisory statements. See our web page providing guidance documents and regulatory 

information regarding food allergens (Table 11-8) for our policy statements and other guidance 

relevant to allergen advisory statements. You should periodically check that web page for 

updates to these policy statements and other guidance.

11.9.2 Justification by Your Preventive Controls Qualified Individual That an 

Allergen Advisory Statement Is Appropriate

We realize that there may be circumstances in which you are not always able to provide 

assurance, even after implementation of appropriate CGMP measures and allergen crosscontact controls, that food can be protected from allergen cross-contact. If so:

o Your PCQI should provide a written justification, in your food safety plan, for why 

allergen cross-contact controls cannot ensure protection of food from allergen crosscontact; and

o Your labeling for the applicable food product(s) could include information that discloses 

the possible unintended allergen presence in the food.

The allergen labeling guidance (see Table 11-7) reiterates the statement in the 1996 food 

allergen notice that that allergen advisory statements such as "may contain [allergen]" should 

not be used as a substitute for adherence to CGMPs and adds that any allergen advisory 

statement such as "may contain [allergen]" must be truthful and not misleading. In developing 

information that is truthful and not misleading and discloses the possible unintended allergen 

presence in the food, you should carefully consider how to design and place the information so 

that it will be easily seen by consumers looking for this additional information on the label.

11.9.3 Suppliers That Use Allergen Advisory Statements

We realize that there may be circumstances in which a supplier that produces some ingredients 

that contain a food allergen, and other ingredients that do not contain a food allergen, may not 

be able to provide assurance that its food products have been protected from allergen crosscontact, even after implementation of appropriate CGMP measures and allergen cross-contact 

controls, and therefore provides allergen advisory statements for the raw materials and other 

ingredients that you would receive from that supplier. We recommend that your supplier 

approval and verification activities include an evaluation of whether a potential supplier provides 

allergen advisory statements for raw materials and other ingredients that you would receive 

from the potential supplier before approving the supplier. When a potential supplier would 

provide allergen advisory statements on the applicable raw materials or other ingredients, we 

recommend that you discuss the reasons for the allergen advisory statements with the potential 

supplier. You should approve a supplier that provides allergen advisory statements for its 

products only if you determine that such statements are not being used in lieu of adherence to 

CGMPs or in lieu of adherence to the requirements for allergen cross-contact controls. 
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If you approve a supplier that provides allergen advisory statements for food products that you 

would receive from that supplier, your PCQI should provide, in your food safety plan, a written 

determination of whether:

• The allergen advisory statement has no impact on the food allergen profile of your products, 

because all products that would contain the affected ingredient also include an ingredient 

that is (or contains) the food allergen that could be present in the ingredient due to allergen 

cross-contact at the supplier and, thus, your product labels already declare the food source 

of that food allergen;

• You will carry an allergen advisory statement forward to one or more of your food products

produced using those raw materials and other ingredients. If so, your Label Content 

Procedures for receiving these ingredients should specify that you treat these ingredients in 

the same manner as you treat ingredients that are or contain a major food allergen37; or

• You will rely on a scientifically valid determination (which you include in your food safety 

plan) that the amount of food allergen that may be present in labeled food products 

produced using that supplier’s ingredient is low enough such that its presence may not 

cause allergic reactions in most consumers who have that food allergy. 

11.9.4 Reanalysis of Your Determination That Allergen Advisory Statements

Are Appropriate If You Experience Ongoing Problems with Your Allergen 

Cross-Contact Controls or Your Supply-Chain Program

The requirements of part 117 for reanalysis specify that you must conduct a reanalysis of the 

food safety plan as a whole, or the applicable portion of the food safety plan whenever you find 

that a preventive control, combination of preventive controls, or the food safety plan as a whole 

is ineffective. (See 21 CFR 117.170(b)(4).) Reanalysis of your allergen cross-contact controls, 

including your determination of whether allergen advisory statements are appropriate, is 

appropriate if you experience ongoing problems with implementation of those controls. Likewise, 

reanalysis of your supply-chain program is appropriate if you experience ongoing supplier 

nonconformance with respect to allergen cross-contact. If your food safety plan does not 

provide for the use of allergen advisory statements, reanalysis of your allergen cross-contact 

controls or your supply-chain program could lead you determine that you are not always able to 

provide assurance, through your allergen cross-contact controls or your supply-chain program, 

that food can be protected from allergen cross-contact, despite using appropriate CGMPs and 

preventive controls. If so:

• You should revise your food safety plan to include a written justification for why allergen 

cross-contact controls or your supply-chain program cannot ensure protection of food from 

allergen cross-contact;

• Your labeling for the applicable food product(s) should include information that discloses the 

possible unintended allergen presence in the food and must be truthful and not misleading; 

and

• In developing allergen advisory statements following reanalysis, you should carefully 

consider how to design and place an allergen advisory statement to call it to the attention of 

a consumer who is allergic to a major food allergen and checks the ingredient statements 

and “Contains” statements on a product label for the food source of all ingredients that are, 

37 See the discussion in section 11.7.1.1.4 regarding Label Content Procedures for receipt of raw 

materials and other ingredients.
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or contain, that major food allergen when first making a purchase selection but may not 

continue to check the ingredient statements and “Contains” statements on that product label 

when purchasing the same product on multiple occasions.

11.10 Training

As required by 21 CFR 117.4(b), each individual engaged in manufacturing, processing, 

packing, or holding food (including temporary and seasonal personnel) or in the supervision 

thereof must:

• Be a qualified individual as that term is defined in 21 CFR 117.3—i.e., have the education, 

training, or experience (or a combination thereof) necessary to manufacture, process, pack, 

or hold clean and safe food as appropriate to the individual's assigned duties; and

• Receive training in the principles of food hygiene and food safety, including the importance 

of employee health and personal hygiene, as appropriate to the food, the facility and the 

individual's assigned duties. (See 21 CFR 117.4(b).)

In addition, supervisory personnel who are responsible for ensuring compliance by individuals 

with the requirements of part 117 must have the education, training, or experience (or a 

combination of these) necessary to supervise the production of clean and safe food. (See 21 

CFR 117.4(c).) Records that document required training must be established and maintained.

(See 21 CFR 117.4(d).)

The successful control of food allergens depends on the involvement of all personnel in all 

phases of product development, ingredient procurement/sourcing, receiving, production and 

distribution of foods, and proper action by employees to control food allergens depends on their 

understanding of their responsibilities (GMA, 2009). Therefore, we recommend that all 

individuals (including individuals with responsibility for management, research and development, 

marketing, procurement, legal/regulatory issues, auditing, product development, design 

engineering, production, quality assurance, consumer complaints, and warehousing and 

distribution) receive general allergen awareness training. Such training should include 

information on the significance of food allergens, proper control of product labeling, and the 

prevention of allergen cross-contact, including the specific practices and procedures employed 

by your establishment.

Examples of training topics for all personnel are:

• Awareness of those raw materials and other ingredients that contain food allergens and that 

should be the subject of a food allergen program; 

• How the design of your plant and equipment helps to prevent allergen cross-contact;

• Procedures that you use to prevent allergen cross-contact – e.g., procedures for storage (of 

raw materials and other ingredients, WIP, rework, and finished products), production 

scheduling, cleaning, rework, packaging products, labeling products, and waste 

management;
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• CGMP measures to prevent allergen cross-contact due to personnel practices, including 

hand washing, use of protective clothing, proper disposal and cleaning of soiled clothing and 

protective gear, and traffic patterns for personnel to move through the plant;

• CGMP measures to prevent allergen cross-contact when moving equipment, maintenance 

tools, and utensils throughout the plant; and

• Actions to take when unintended allergen presence is suspected. 

 

See Table 11-5 for examples of training topics appropriate to an individual’s assigned duties. 

Table 11-5 Examples of Training Topics Appropriate to an Individual’s Assigned Duties

Personnel Function Training Topics 

Purchasing Awareness that food allergen hazards may require supply-chain controls

with associated supplier approval and verification activities

Receiving Procedures for receipt, handling, and storage of allergen-containing raw 

materials and other ingredients to ensure that they are appropriately 

identified and stored

Production operations The food allergen control measures employed during production, including 

the preventive measures, corrective actions, and records applicable to each 

employee’s position

Management of WIP and 

rework 

Awareness of the importance of controlling WIP and rework to prevent 

allergen cross-contact

Maintenance Measures to prevent allergen cross-contact (e.g., through maintenance

tools) between production lines 

Cleaning operations Awareness of the key role of cleaning procedures in preventing allergen 

cross-contact

Supervision The plant’s food allergen program applicable to the supervisory 

responsibilities

11.11 Examples Used in this Chapter

Sections 11.12 and 11.13 of this chapter provide examples to illustrate how to establish and 

implement a food allergen program. These examples are:

• Food Allergen Program Established and Implemented by Dessert Manufacturer A for the 

Production of Ice Cream and Other Frozen Dessert Products; and

• Food Allergen Program Established and Implemented by Bakery B for the Production of a 

Variety of Cookie Products.

In reviewing these examples, keep in mind that: 

• Our purpose in providing multiple, detailed recommendations in each example is to provide 

as many examples as possible so that you can develop your own food allergen program as 
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appropriate to your operations, not to imply that a food allergen program should have all the 

CGMP measures, preventive controls (including supply-chain controls), 

monitoring/verification activities, corrective action procedures, and records that we describe 

in each example for illustrative purposes.

• Label controls have a role in ensuring that the finished food will not be misbranded under 

section 403(w) of the FD&C Act. Putting a label control in place to prevent such misbranding 

is more important than classifying that control in a particular way (e.g., as a label content 

control or a label management control). 

• You have flexibility to determine what monitoring/verification activities, and how many 

monitoring/verification activities, are appropriate for your operation to ensure the 

effectiveness of the preventive control. (See 21 CFR 117.140(a).) For the purpose of these 

examples, we specified how Dessert Manufacturer A or Bakery B classified an activity as 

either monitoring or verification and retained that classification throughout the examples. 

• Regardless of whether you identify a label control as a label content control or a label 

management control, you have flexibility to conduct a single activity as 

monitoring/verification for either type of label control, and you also have flexibility to use a 

single record to document either type of label controls.

As noted in sections 11.1 and 11.4.3, this chapter does not broadly discuss issues associated 

with allergen advisory statements. Accordingly, the examples in sections 11.12 and 11.13 do 

not discuss whether and how a manufacturer/processor would determine that allergen advisory 

statements are, or are not, appropriate.

11.12 Example of a Food Allergen Program Established and 

Implemented by Dessert Manufacturer A for the Production of Ice 

Cream and Other Frozen Dessert Products

11.12.1 Dessert Manufacturer A’s Products and Hazard Analysis

Dessert Manufacturer A produces four frozen dessert products on the same processing line:

• Raspberry sorbet, which contains no ingredients that are, or contain, a food allergen;

• Vanilla ice cream, which contains two ingredients that are, or contain, a food allergen (i.e., 

cream and milk powder);

• Vanilla frozen custard, which contains three ingredients that are, or contain, a food allergen 

(i.e., cream, milk powder, and pasteurized liquid eggs); and 

• Vanilla frozen custard with almonds, which contains four ingredients that are, or contain, a 

food allergen (i.e., cream; milk powder; pasteurized liquid eggs; and dry-roasted, chopped 

almonds).

The manufacturing process is as follows:

• Mix ingredients (except for almonds added to vanilla frozen custard with almonds) to form a 

dessert mix;

• Homogenize the dessert mix (for the ice cream and custard mixes);
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• Heat process (i.e., pasteurize) the dessert mix in a high-temperature-short-time (HTST) 

pasteurizer;

• Partially freeze the heat-treated dessert mix in a scraped-surface freezer; and

• Pump the partially frozen heat-treated dessert mix into 56-ounce plastic-coated paperboard 

tubs that are the product packaging; for the vanilla frozen custard containing almonds, the 

almonds are added during this step.

o The tubs have a pre-printed product label, including the product name and ingredient 

statement. The tubs also have a barcode that is used for multiple purposes, such as 

inventory management.

o The lids are pre-printed with the product name.

Through the hazard analysis, Dessert Manufacturer A’s PCQI determines that a food allergen 

program, with one or more preventive controls, is necessary to ensure protection of the frozen 

desserts from allergen cross-contact and to ensure that the finished frozen desserts are not 

misbranded under section 403(w) of the FD&C Act.

11.12.2 Dessert Manufacturer A’s Food Allergen Program

11.12.2.1 Dessert Manufacturer A’s CGMP measures in its food allergen 

program

In determining the appropriate preventive controls, Dessert Manufacturer A first considers the 

measures that it has established to satisfy the CGMP requirements to prevent allergen crosscontact. Dessert Manufacturer A has CGMP measures in place at the following operational 

stages:

• Receipt of ingredients: Dessert Manufacturer A uses color-coded stickers/tags to designate 

totes/containers of allergenic ingredients – cream and milk powder have white stickers/tags, 

pasteurized liquid eggs have yellow stickers/tags, and almonds have brown stickers/tags.

• Storage of ingredients: Dessert Manufacturer A:

o Segregates (i.e. stores in a different area) allergenic ingredients (cream, milk powder, 

pasteurized liquid eggs, and almonds) from non-allergenic ingredients (e.g., sugar, 

flavorings, and coloring).

o Dedicates one cold storage unit to allergens, with closed, clearly marked, plastic totes of 

cream and plastic bags (in boxes) of pasteurized liquid eggs segregated on separate 

sides of the unit.

o Stores almond pieces (in boxes with liners) and milk powder (in plastic bags) in 

dedicated bays in the warehouse. 

o Specifies in production procedures that partially-used containers be closed before they 

are returned to the cooler or warehouse.

• Scheduling: Dessert Manufacturer A produces the frozen products in a sequence whereby 

the product with no allergens (i.e., raspberry sorbet) is produced first and the product with 

the most allergens (i.e., vanilla frozen custard with almonds) is produced last. The complete 

sequence of products manufactured on the line is as follows: raspberry sorbet, vanilla ice 

cream, vanilla frozen custard, and vanilla frozen custard with almonds.

• Staging: Dessert Manufacturer A:
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o Uses separate areas to weigh or measure out non-allergenic ingredients (e.g., sugar, 

flavoring, and colors) and allergenic ingredients (cream, milk powder, pasteurized liquid 

eggs, and almonds) before staging the ingredients next to the line. Only one allergenic 

ingredient is weighed/measured at a time, the area is cleaned, and any partially-used 

containers are closed and returned to the cooler or warehouse before another ingredient 

is weighed/measured to prevent cross-contact of any partially-used ingredients. 

o Dedicates (i.e., to a specific food allergen or to non-allergenic ingredients) tools, 

containers, and equipment used to measure ingredients, using the same color-coding 

used on the containers of allergen-containing ingredients.

o Prepares the weighed/measured ingredients as needed, identifies them on a sticker 

(name and amount), and takes them directly to the production line. 

• Processing: Dessert Manufacturer A adds the almonds at the end of the production process

to minimize the number of pieces of processing equipment that contact the almonds.

• Cleaning: Dessert Manufacturer A uses freshly prepared cleaning solutions to clean all 

equipment and utensils in the production line immediately after production of each product is 

complete.

11.12.2.2 Dessert Manufacturer A’s food allergen controls

Because Dessert Manufacturer A processes foods with different allergen profiles on the same 

processing line, Dessert Manufacturer A’s PCQI determined that an allergen cross-contact 

control during its production of frozen desserts is necessary to ensure protection of the frozen 

desserts from allergen cross-contact.

Because three of Dessert Manufacturer A’s dessert products contain ingredients that are or 

contain a food allergen, Dessert Manufacturer A’s PCQI determined that label controls are 

necessary to ensure that its frozen dessert products are not misbranded under section 403(w) 

of the FD&C Act.

11.12.2.3 Dessert Manufacturer A’s assessment of supply-chain 

controls related to food allergens

Dessert Manufacturer A’s PCQI assessed whether Dessert Manufacturer A needs to establish 

and implement a supply-chain control to ensure that the plants that supply cream, milk powder, 

liquid pasteurized eggs, and dry-roasted, chopped almonds significantly minimize or prevent 

allergen cross-contact. 

o Through its supply-chain programs for the control of biological hazards in cream, milk 

powder, and pasteurized liquid eggs, Dessert Manufacturer A has determined that the 

suppliers of cream, milk powder, and pasteurized liquid eggs do not process other food 

allergens. Therefore, Dessert Manufacturer A’s PCQI determined that Manufacturer A 

does not need to assess the potential for allergen cross-contact at the suppliers for the 

cream, milk powder, and pasteurized liquid eggs.

o Through its supply-chain program for the supplier’s dry-roasting process for the control 

of Salmonella hazards in the dry-roasted, chopped almonds, Dessert Manufacturer A 

has determined that the almond handlers that dry roast and chop the almonds do not 

handle other tree nuts or other food allergens. Therefore, Dessert Manufacturer A’s 
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PCQI determined that Dessert Manufacturer A’s supply-chain program for the receipt of 

dry-roasted, chopped almonds does not need to assess the potential for allergen crosscontact at the almond handlers’ plants. 

11.12.3 Dessert Manufacturer A’s Allergen Cross-Contact Control

11.12.3.1 Dessert Manufacturer A’s allergen cleaning procedures

Under the production sequence established by Dessert Manufacturer A, the first product in the 

production sequence contains no allergenic ingredients. After that first product, each successive 

dessert on the production line contains allergenic ingredients, including allergenic ingredients

that were in the previous dessert processed on the production line as well as one additional 

allergenic ingredient, until all four products have been processed and the production sequence 

starts again. After processing the final product in the production sequence (i.e., the vanilla 

custard with almonds, which contains four allergenic ingredients) the next product to be 

processed contains no food allergens (i.e., raspberry sorbet). Therefore, Dessert Manufacturer 

A’s PCQI determined that:

• The production sequence, coupled with general cleaning measures established in 

accordance with the CGMP requirements of 21 CFR 117.35, is adequate to prevent allergen 

cross-contact after the processing of each of the first three products in the production 

sequence (i.e., after the processing of raspberry sorbet, vanilla ice cream, and vanilla 

custard without almonds); 

• General cleaning measures established in accordance with the CGMP requirements of 21 

CFR 117.35 alone are not adequate to prevent allergen cross-contact after the processing

of the final product in the production sequence (i.e., after processing of vanilla almond 

custard with almonds), because the production sequence begins again with raspberry 

sorbet, which contains no allergenic ingredients. Thus, allergen cleaning procedures that are

targeted to the removal of all allergenic food residues from FCSs are needed as a 

preventive control to prevent allergen cross-contact after the production of vanilla custard 

with almonds; and 

• If circumstances arise in which the customary production sequence is altered, the allergen

cleaning procedures (rather the general cleaning measures) are needed between production 

runs when a previous dessert product on the production line contains at least one allergenic 

ingredient not present in the subsequent production run. 

Dessert Manufacturer A develops its allergen cleaning procedures in consultation with its 

provider of food hygiene services and cleaning compounds and with the Quality Assurance 

supervisor who will oversee periodic analytical tests to verify the results of visual inspection after 

a cleaning cycle.

11.12.3.2 Dessert Manufacturer A’s monitoring/verification of allergen 

cleaning procedures

Dessert Manufacturer A conducts the following activities to monitor/verify that its allergen 

cleaning procedures are preventing allergen cross-contact: 
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• During each cleaning procedure to remove allergenic food residues, the Sanitation 

Supervisor uses a checklist (the “allergen cleaning checklist”) to monitor each step in the 

allergen cleaning procedure and note any corrections taken during the cleaning procedure.

After the equipment has been cleaned and visually inspected, the Sanitation Supervisor 

uses an ATP bioluminescence swab test or a protein swab test to verify that the line is 

clean. The Sanitation Supervisor notes the monitoring and results of the ATP swab test or 

protein swab test on the allergen cleaning checklist.

• Before each production run of raspberry sorbet (or before running any product that does not 

contain an allergenic ingredient present in the previous run), the Sanitation Supervisor 

conducts and documents a pre-operational visual inspection of applicable processing 

equipment and utensils as monitoring that they are visibly clean and notes if the visual 

inspection demonstrates that the allergen cleaning procedure needs to be repeated (the 

“pre-operational visual inspection record”).

• On a quarterly basis, and whenever there is a change in the cleaning procedure, a Quality 

Assurance technician verifies the visual inspection by conducting allergen-specific analytical 

tests before a production run of raspberry sorbet that follows a run of vanilla custard with 

almonds and keeps the analytical test results as a record.

• On a weekly basis, Dessert Manufacturer A’s PCQI reviews the allergen cleaning checklists 

as verification that all equipment and utensils have been cleaned prior to production, and 

documents that record review by initialing and dating the allergen cleaning checklists. 

• On a weekly basis, Dessert Manufacturer A’s PCQI reviews the pre-operational visual 

inspection records and documents that record review by initialing and dating the preoperational visual inspection records.

• Within a week of any allergen-specific analytical tests to verify the visual inspection, Dessert 

Manufacturer A’s PCQI reviews the results of the analytical tests as verification, and 

documents that record review by initialing and dating the results. 

• Within a week of a problem that requires corrective action, Dessert Manufacturer A’s PCQI 

reviews the corrective action records, and initials and dates each of the records reviewed in 

the place marked “Verified by.”

11.12.3.3 Dessert Manufacturer A’s corrective actions/corrections for 

allergen cleaning procedures

• Corrections. If the Sanitation Supervisor observes, during monitoring, that a step in the 

allergen cleaning procedure has not been properly implemented, the Sanitation Supervisor 

directs personnel to repeat the full cleaning procedure before beginning the next production 

run and notes this action on the allergen cleaning checklist. Similarly, if the ATP or protein 

swab tests indicate that the equipment has not been adequately cleaned, the Sanitation 

Supervisor directs personnel to repeat the full cleaning procedure, verifies the cleaning with 

an ATP or protein swab test, and notes this action on the allergen cleaning checklist. 

• Corrective actions. If a routine analytical test detects unintended allergen presence in 

raspberry sorbet, or if a consumer who has an allergy to egg, milk, or almonds reports an 

allergic reaction to raspberry sorbet:

o If the problem was identified through a consumer report of an allergic reaction, 

Manufacturer A investigates whether there were production issues that could have 

contributed to unintended allergen presence, conducts product testing on samples that it 

retained of the applicable lot to confirm the unintended allergen presence and, if there is 
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unintended allergen presence, determine the extent of the problem (e.g., number of 

affected lots).

o The Production Manager conducts a root cause investigation to try to determine 

whether:

 Allergen cleaning procedures were not properly implemented (e.g., a complete clean 

was not conducted during an out-of-sequence changeover to raspberry sorbet to 

fulfill an order); or 

 The allergen cleaning procedures are not effective (e.g., if it is determined that there 

is a place where a particle can get hung up on the equipment, thus requiring 

disassembly of that part of the equipment for cleaning before a production run for 

raspberry sorbet);

o When appropriate based on the root cause of the problem, the Production Supervisor:

 Re-trains sanitation managers/personnel (e.g., if it is determined that the allergen 

cleaning procedures were not properly implemented);

 Revises the allergen cleaning procedures (e.g., if it is determined that the allergen 

cleaning procedures are not effective); 

 Appropriately disposes of impacted lots of raspberry sorbet that have not yet been 

distributed; and

 Arranges for recalls of affected lots of raspberry sorbet that are in commerce and are 

adulterated under section 402(a)(4) of the FD&C Act due to allergen cross-contact. 

11.12.3.4 Dessert Manufacturer A’s records for allergen cleaning

procedures and associated preventive control management components

Dessert Manufacturer A maintains the following records:

• Its SSOP, which includes:

o Procedures for cleaning FCSs to remove all allergenic food residues; and

o Forms it will use for documentation of carrying out the written procedures, for monitoring 

and verification activities and for corrections and corrective actions (the forms may serve 

the dual purpose of written procedures and documentation) and; 

• The following records that are dated and initialed by the PCQI to document review of the 

records:

o The allergen cleaning checklists for each cleaning cycle;

o Pre-operation visual inspection records of the production line; 

o Results of any analytical test conducted to verify the results of visual inspection; and

o Any corrective action records.

11.12.4 Dessert Manufacturer A’s Label Controls

11.12.4.1 Dessert Manufacturer A’s label content controls and label 

management controls

11.12.4.1.1 Label content

Dessert Manufacturer A applies the following Label Content Procedures during the development 

and production of product packaging:
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• Label development stage: The product development specialist develops a food allergen 

label specification by reviewing the ingredients listed in the recipe or formulation, and the 

components listed by suppliers for all ingredients, to identify all food allergens in each 

product and the food source of each allergenic ingredient or component.

o The product development specialist notes that the food allergens in the ingredients are 

as follows:

 Raspberry sorbet: There are no allergenic ingredients. 

 Vanilla ice cream: The allergenic ingredients are cream and milk powder. The name 

of the food source for both ingredients is milk. 

 Vanilla frozen custard: The allergenic ingredients are cream, milk powder, and 

pasteurized liquid eggs. The names of the food sources are milk and eggs.

 Vanilla frozen custard with almonds. The allergenic ingredients are cream, milk 

powder, pasteurized liquid eggs, and dry-roasted, chopped almonds. The names of 

the food sources are milk, eggs, and almonds.

o The product development specialist notes that the name of the food source of all

allergenic ingredients is included as a part of the common or usual name of at least one

ingredient38 that contains the allergen, i.e., “milk powder,” “eggs,” and “almonds” and 

that there are no additional allergenic components in other ingredients.

o The product development specialist decides that the label specification for naming the 

food sources of the major food allergens that are ingredients in the dessert products is 

the ingredient statement declaring the allergenic ingredients as follows:

 Vanilla ice cream: The ingredient statement declares milk powder.

 Vanilla custard: The ingredient statement declares milk powder and eggs.

 Vanilla custard with almonds: The ingredient statement declares milk powder, eggs, 

and almonds.

o The food allergen label specification includes a requirement for each tub to be colorcoded through a different colored band on the top edge of the tub (red for the raspberry 

sorbet, blue for the vanilla ice cream, yellow for the custard without almonds, and brown 

for the custard with almonds).

o The product development specialist decides that the product name39 will be pre-printed 

on the lid for the tub and, thus, that the food allergen label specification will include a 

requirement for each lid to be color-coded, on a band surrounding the edge of the lid, 

using the same color-coding as for the tubs (red for the raspberry sorbet, blue for the 

vanilla ice cream, yellow for the custard without almonds, and brown for the custard with 

almonds). 

o The Label Coordinator reviews the food allergen label specification and documents 

approval by signing and dating it.

• Ordering stage: 

38 The food source of the allergenic ingredient “cream” is declared as part of the common or usual name 

of another ingredient (i.e., milk powder). 

39 Note that a label management control applies to labeling associated with food allergens. If the lid does 

not provide any label information (such as the product name, the ingredient statement, or a “Contains”

statement) applicable to the food allergen profile of the product, a color code for a lid (e.g., to complement 

the color code on the tub) would not be a label management control, because the wrong color of lid would 

not be relevant to the question of whether the product is misbranded under section 403(w) of the FD&C 

Act.
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o The Label Coordinator reviews a mock-up of the product label, provided by the 

manufacturer of the tubs and lids, and confirms that the mock-up matches the food 

allergen label specification before authorizing a production run of the tubs and lids.

o The purchase order for the product tubs and lids specifies that the product tubs/lids for 

the different products be shipped on different pallets.

11.12.4.1.2 Label management

Dessert Manufacturer A applies Label Management Procedures during storage, staging, 

production, and post-production. Dessert Manufacturer A stores tubs and lids in boxes on 

pallets with a sticker containing the product name and carton size on the outside of the box.

When tubs and lids are brought to the staging area for packaging, production personnel check 

product name and the ingredient statement printed on the tub, and the color on the top edge of 

the tub, as well as the product name on the lid and the color of the band of the lid, to confirm 

that the correct tub and lid have been brought to the staging area for packaging. At the end of 

production, Dessert Manufacturer A places unused tubs and lids in the appropriate boxes

containing the product name and carton size and returns them to the warehouse.

11.12.4.2 Dessert Manufacturer A’s monitoring/verification of label 

controls 

Dessert Manufacturer A conducts the activities described in sections 11.12.4.2.1 and 

11.12.4.2.2 to monitor/verify that its label controls are ensuring that its finished frozen dessert 

products are not misbranded under section 403(w) of the FD&C Act.

11.12.4.2.1 Monitoring/verification of label content controls

• Receipt of product packaging (tubs and lids): After the tubs and lids are manufactured and 

delivered to Dessert Manufacturer A, quality assurance personnel verify that the tubs and 

lids match the approved food allergen specification for the product label (including the 

product name and ingredient statement on the tubs and the color of the tubs, as well as the 

product name on the lid and the color of the band of the lid). Quality assurance personnel 

document this review on a Label Review Form included in the Label Content Procedures

and sign and date the form.

• On a weekly basis, Dessert Manufacturer A’s PCQI reviews, initials, and dates the records 

documenting the verification by quality assurance personnel that the tubs and lids match the 

approved food allergen label specification.

• Within a week of a problem that requires corrective action, Dessert Manufacturer A’s PCQI 

reviews the corrective action records, and initials and dates each of the records reviewed in 

the place marked “Verified by.”

11.12.4.2.2 Monitoring/verification of label management controls

• Storage of product packaging (tubs and lids): On a weekly basis, quality assurance 

personnel use a checklist to monitor that the tubs and lids are stored appropriately at receipt 

and following production by observation in the storage area for the tubs and lids and 
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document any incorrect storage on a “Storage Record for Label Controls” form included in 

the Label Management Procedures, and sign and date the form.

• Production (packaging): The line operator monitors and documents the staging check of the 

tubs and lids by observing the stacks of tubs and lids placed on the line at the beginning of 

packaging (and each time new tubs and lids are brought to the packaging line) to confirm 

that the top edge of the tub, and the band on the lid, have the proper color for the product 

being produced (red for the raspberry sorbet, blue for the vanilla ice cream, yellow for the 

custard without almonds, and brown for the custard with almonds). If the monitoring 

demonstrates that the tub or lid is incorrect, the line operator obtains the correct tub or lid

and notes the problem on the production sheet and initialing and dating that note.

• Production (from packaging and code dating through case packing): The line operator 

manually uses a UPC barcode scanner to monitor that the correct tub is being used for the 

various products. This monitoring occurs when the line is initially set up and at hourly 

intervals throughout the production run. The line operator records and initials the results of 

the barcode scanner on the production sheet, along with the date and time of each check.

40

• Post-production: At the end of each production run, the line operator verifies that any 

unused tubs and lids have been placed in the appropriately stickered boxes for return to the 

storage area and notes this post-production verification check on the production sheet. 

• On a weekly basis, Dessert Manufacturer A’s PCQI reviews, initials, and dates:

o Storage Record for Label Controls for monitoring the correct storage of tubs and lids by 

quality assurance personnel.

o The production sheet with:

 Staging checks of the tubs and lids brought to the packaging line; 

 The records documenting the results of the barcode scanning of the production tubs 

when the packaging line is initially set up and at hourly intervals during production; 

and

 The post-production verification check that unused tubs and lids have been placed in 

appropriately stickered boxes for return to storage.

• Within a week of a problem that requires corrective action, Dessert Manufacturer A’s PCQI 

reviews the corrective action records, and initials and dates each of the records reviewed in 

the place marked “Verified by.”

11.12.4.3 Dessert Manufacturer A’s corrective actions/corrections for 

label controls

11.12.4.3.1 Corrective actions/corrections for label content controls

• Corrections: Receiving personnel reject lots of inaccurate/wrong tubs or lids that are sent 

from the packaging manufacturer. Procurement personnel follow up with the packaging 

manufacturer as to the cause of the problem and the steps the packaging manufacturer will 

take to correct the problem and prevent it in the future.

• Corrective actions: If the inaccurate label content is not discovered until after the product is 

packaged, Dessert Manufacturer A takes and documents the following corrective actions:

40In this example, the tub has a bar code but the lid does not. Therefore, the monitoring that the line 

operator conducts using a barcode scanner only applies to the tubs. 
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o Segregation of any incorrectly labeled/packaged products. 

 Mislabeled vanilla ice cream is used as rework in the vanilla ice cream and the 

vanilla custards. 

 Any mislabeled raspberry sorbet or vanilla frozen custard with or without almonds is 

either reworked into the same product during the next production run or discarded. 

o Investigation by the Production Manager of the root cause of incorrectly labeled 

products. The Production Supervisor arranges for modification of the label content

procedures, re-training of personnel, or both as appropriate.

o Initiation of a recall of any product in commerce that is misbranded under section 403(w) 

of the FD&C Act.

11.12.4.3.2 Corrective actions/corrections for label management controls

• Corrections: Dessert Manufacturer A:

o Returns any incorrectly stored tubs or lids to the correct storage location and documents 

the correction on the Storage Record for Label Controls; and

o Removes any tubs from the line if they have the wrong color of band at the top and 

removes any lids from the line if they have the incorrect color of band on the edge and

returns them to storage without documenting the correction.

• Corrective actions: If product is packaged using an incorrect tub or lid, Dessert Manufacturer 

A takes and documents the same corrective actions as for a problem with a label content 

control, except that modifications to the preventive control procedures would affect Label 

Management Procedures rather than Label Content Procedures. (See section 11.12.4.3.1.)

11.12.4.4 Dessert Manufacturer A’s records for label controls and 

associated preventive control management components

11.12.4.4.1 Records for label content controls

Dessert Manufacturer A maintains the following records:

• The Label Content Procedures;

• The approved food allergen label specification, dated and signed by the Label Coordinator.

• The following records, initialed and dated by the PCQI to document review of the records:

o The Label Review Forms, signed and dated by quality assurance personnel, 

documenting that the final packaging (tubs and lids) has been reviewed after receipt 

from the packaging manufacturer and that the product name and ingredient statement 

on the product label, and the color on the top edge of the tubs, as well as the product 

name on the lid and the color of the band of the lid, match the food allergen label 

specification for the product; and

o Any corrective action records.
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11.12.4.4.2 Records for label management controls

Dessert Manufacturer A maintains the following records:

• The Label Management Procedures, including monitoring procedures for checking the color 

of the product tub and lid at staging and the Storage Record for Label Controls form.

• The following records, initialed and dated by the PCQI to document review of the records:

o The Storage Record for Label Controls; 

o The production sheet on which the line operator notes:

 Results of staging checks including any instance in which monitoring demonstrates 

that the wrong tubs or lids were brought to the staging area; and 

 The results of the UPC barcode scanner at the beginning of the production run and 

every hour during the production run; and

 The post-production verification check that any unused tubs and lids have been 

placed in the appropriately stickered box for return to storage; and

o Any corrective action records.

11.12.5 Summary of Dessert Manufacturer A’s Food Allergen Program

Appendix 11-2 summarizes Dessert Manufacturer A’s:

• Allergen cross-contact control on the FSPCA’s Sanitation Control Form (Form 2-D from 

Appendix 2 of this guidance); and

• Label controls on the FSPCA’s Food Allergen Control Form (Form 2-H (modified) from 

Appendix 2 of this guidance).

Appendix 11-2 also provides Dessert Manufacturer A’s:

• Ingredient analysis to support both allergen cross-contact controls and label controls (Form 

2E (Modified) from Appendix 2 of this guidance);

• Food allergen verification list to support label controls (Form 2F (Modified) from Appendix 2

of this guidance); and 

• Production line food allergen assessment to support allergen cross-contact controls (Form

2G (Modified) from Appendix 2 of this guidance). 

11.13 Example of Food Allergen Program Established and 

Implemented by Bakery B for the Production of a Variety of Cookie 

Products

11.13.1 Bakery B’s Products and Hazard Analysis

Bakery B produces three types of cookies, for milk allergic-consumers, that have no ingredients 

containing milk:
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• Oatmeal cookies, which contain two ingredients that are, or contain, a food allergen: flour 

(wheat) and pasteurized liquid eggs;

• Caramel chip cookies, which contain:

o Two ingredients that are, or contain a food allergen: flour (wheat) and pasteurized liquid 

eggs; and

o One ingredient (i.e., vegan caramel chips) that does not contain a food allergen but has

the potential to contain a food allergen (i.e., milk) as a result of allergen cross-contact by 

suppliers that produce non-vegan caramel, milk chocolate, and butterscotch chips that 

contain milk; and

• Peanut butter cookies, which contain three ingredients that are, or contain, food allergens: 

flour (wheat), pasteurized liquid eggs, and peanut butter (peanuts).

All three cookies contain vegetable shortening, which contains soy. However, Bakery B sources 

its vegetable shortening from suppliers that produce vegetable shortening from highly refined 

soybean oil, which is exempt from the allergen labeling requirements of the FD&C Act. (See 

section 201(qq)(2)(A) of the FD&C Act.)

The manufacturing process is as follows:

• Dough preparation: 

o For oatmeal cookies: Mix the base ingredients (wheat flour, eggs, vegetable shortening, 

vanilla extract, salt, baking soda, brown sugar, and granulated sugar) in a spiral mixer,

then add oatmeal and raisins. 

o For caramel chip cookies: Mix the same base ingredients as used for the oatmeal 

cookies in a spiral mixer, then add caramel chips. 

o For peanut butter cookies: Mix the same base ingredients as used for the oatmeal 

cookies in a spiral mixer, then add peanut butter. 

• Dough depositing and baking: Form cookies using a dough depositor and bake them on 

parchment-lined aluminum cookie sheets in a rotating rack oven.

• Packaging: After baking, hand-pack cookies into plastic trays that are placed in in plasticlined paper pouches.

• Labeling: Label the plastic-lined paper pouches, already filled with cookies, with labels that

are computer-generated in-house. The labels are printed and applied during production 

(rather than printed in advance of production and stored until needed).

Through its hazard analysis, Bakery B’s PCQI determines that a food allergen program, with

one or more preventive controls, is necessary to ensure protection of the cookies from allergen 

cross-contact and ensure that the finished cookies are not misbranded under section 403(w) of 

the FD&C Act.
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11.13.2 Bakery B’s Food Allergen Program

11.13.2.1 Bakery B’s CGMP measures in its food allergen program

In determining the appropriate preventive controls, Bakery B first considers the measures that it 

has established to satisfy the CGMP requirements to prevent allergen cross-contact. Bakery B 

has CGMP measures in place at the following operational stages:

• Storage of ingredients: The peanut-containing ingredient (peanut butter) is segregated from 

other ingredients in a separate warehouse bay that has signs “Only for Peanut Butter.”

• Separation in space. Although all cookie products are produced in the same plant:

o The peanut butter cookies are produced and packaged on a different processing line 

(with different equipment, utensils and tools) than the oatmeal cookies and caramel chip 

cookies.

o The production areas for weighing the peanut butter and for staging the peanut butter 

cookie ingredients are physically separated by a wall and door from the rest of the 

production areas – next to the peanut butter cookie line but away from the production 

area for the oatmeal cookies and caramel chip cookies.

11.13.2.2 Bakery B’s food allergen controls

Bakery B’s CGMP measures segregate the processing line for cookies containing peanuts from 

the processing line for cookies that do not contain peanuts. Although Bakery B processes two 

different cookies (i.e., oatmeal cookies and caramel chip cookies) on the same production line, 

these cookies have the same food allergen profile. Therefore, Bakery B’s PCQI determined that 

general cleaning measures established in accordance with the CGMP requirements of 21 CFR 

117.35 for cleaning FCSs, coupled with its segregation of processing lines, are adequate to 

clean its production lines and sanitation controls to prevent allergen cross-contact are not 

needed for the production line equipment. However, due to the severity of allergic reactions in 

consumers who are allergic to peanuts, Bakery B’s PCQI determined that allergen cross-contact 

controls on utensils, tools, apparel, and movement of personnel are necessary to ensure 

protection of the oatmeal cookies and caramel chip cookies from allergen cross-contact with 

peanut protein.

Because all of Bakery B’s cookies contain ingredients that are or contain a food allergen,

Bakery B’s PCQI determined that label controls are necessary to ensure that its cookies are not 

misbranded under section 403(w) of the FD&C Act.

11.13.2.3 Bakery B’s assessment of supply-chain controls related to 

food allergens

Bakery B’s PCQI assessed whether Bakery B needs to establish and implement a supply-chain 

control to ensure that the plants that supply caramel chips, flour, eggs, vegetable shortening,

and peanut butter significantly minimize or prevent allergen cross-contact.

• Bakery B’s PCQI determined that the vegan caramel chips have the potential for unintended 

milk presence as a result of allergen cross-contact by both potential suppliers, because 
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each potential supplier produces non-vegan chips (caramel, milk chocolate, and 

butterscotch chips that contain milk) in addition to vegan caramel chips. Therefore, Bakery 

B’s PCQI determined that supply-chain controls are necessary to ensure that the caramel 

chips are protected from allergen cross-contact.

• Through its initial discussions with potential suppliers of flour, Bakery B has determined that 

the suppliers of flour do not handle food allergens other than wheat. Therefore, Bakery B’s 

PCQI determined that Bakery B’s supply-chain program for the receipt of flour does not 

need to assess the potential for allergen cross-contact at the suppliers’ plants. 

• Through its initial discussions with potential suppliers of pasteurized liquid eggs, Bakery B 

has determined that the suppliers of pasteurized liquid eggs do not handle other food 

allergens. Therefore, Bakery B’s PCQI determined that Bakery B does not need to assess 

the potential for allergen cross-contact at the suppliers for pasteurized liquid eggs. 

• Through its initial discussions with potential suppliers of vegetable shortening, Bakery B has 

determined that the suppliers of vegetable shortening do not handle food allergens other 

than soy and all suppliers produce vegetable shortening from highly refined soybean oil, 

which is exempt from the allergen labeling requirements of the FD&C Act. (See section 

201(qq)(2)(A) of the FD&C Act.) Therefore, Bakery B’s PCQI determined that Bakery B does 

not need to assess the potential for allergen cross-contact at the suppliers for vegetable 

shortening.

• Through its initial discussions with potential suppliers of peanut butter, Bakery B has 

determined that the suppliers of peanut butter do not handle food allergens other than 

peanuts. Therefore, Bakery B’s PCQI determined that Bakery B does not need to assess the 

potential for allergen cross-contact at the suppliers for peanut butter.

11.13.3 Bakery B’s Allergen Cross-contact Controls 

11.13.3.1 Bakery B’s allergen cross-contact controls on utensils, tools, 

apparel, and movement of personnel

Bakery B establishes and implements allergen cross-contact controls on utensils, tools, and 

apparel and on the movement of personnel as follows:

• Dedicated utensils, tools, and apparel:

o Bakery B dedicates all utensils (e.g., scoops, spatulas) and tools (e.g., scrapers, 

brushes) used in the production of the peanut butter cookies so that they are not used 

for the production of oatmeal cookies or caramel chip cookies. Bakery B color-codes all 

utensils and tools (peanut - blue; non-peanut - white) to make it visibly obvious if the

incorrect utensil or tool is brought into the production area.

o Bakery B dedicates all apparel (e.g., smocks, hairnets) used in the production of the 

peanut butter cookies so that they are not used for the production of oatmeal cookies or 

caramel chip cookies. Bakery B color-codes all apparel (peanut - blue; non-peanut -

white) to make it visibly obvious if the incorrect apparel is brought into the production 

area.

• Restricted personnel movement in the plant: Bakery B restricts the movement of personnel 

in the plant by assigning personnel to work exclusively on the peanut butter cookie line or 
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the production line used for oatmeal cookies and caramel chip cookies during any given 

production shift.

11.13.3.2 Bakery B’s monitoring/verification of allergen cross-contact 

controls 

Bakery B conducts the following activities to monitor/verify that its allergen cross-contact 

controls are preventing allergen cross-contact: 

• During each shift, the Production Supervisor for each cookie processing area monitors the 

utensils and tools in the area for the correct color (peanut - blue; non-peanut - white) by 

visual observation. The Production Supervisor documents the monitoring and any nonconformance on a “Checklist for Allergen Cross-Contact Controls.”

• During each shift, the Production Supervisor for each cookie processing area monitors

personnel for the appropriate color smocks and hairnets by visual observation and 

documents the monitoring on a “Checklist for Allergen Cross-Contact Controls.”

• On a weekly basis, Bakery B’s PCQI reviews the Checklist for Allergen Cross-Contact 

Controls (including corrective actions when applicable) and documents that verification 

review by initialing and dating the record in the place marked “Verified by.”

11.13.3.3 Bakery B’s corrective actions/corrections for allergen crosscontact controls

• If a Production Supervisor finds utensils or tools in the wrong production area, the 

Production Supervisor removes the item and takes it to the cleaning room for washing 

before it is returned to the correct production area. The Production Supervisor determines, if 

possible, how the utensil or tool was brought into the wrong processing area and ensures 

that personnel are re-trained as appropriate based on the determination of the root cause of 

the problem.

o Corrections: If production has not begun, these activities are corrections and the 

Production Supervisor does not document the correction on the Checklist for Allergen 

Cross-Contact Controls. 

o Corrective actions: If production has begun, these activities are corrective actions and 

are documented on the Checklist for Allergen Cross-Contact Controls. The Production 

Supervisor determines whether product may have been affected (i.e. whether product 

may have come in contact with peanut protein), and, if so, evaluates any affected 

cookies for safety and prevents affected food from entering commerce by re-processing 

affected oatmeal or caramel chip cookie dough base (prior to addition of oatmeal and 

raisins or caramel chips) as peanut butter cookies or diverting the affected oatmeal 

cookies or affected caramel chip cookies or dough to animal food.

• If a Production Supervisor finds personnel wearing the incorrect color of smock or hairnet, 

the Production Supervisor determines whether the incorrect color was due to putting on the 

wrong item(s) (and, if so, why) or due to a violation of the plant traffic pattern procedures 

such that personnel from the peanut butter cookie area entered the oatmeal/caramel chip 
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cookie production area. The Production Supervisor ensures that personnel are re-trained as 

appropriate based on the determination of the root cause of the problem.

o Corrections: If the employee put on the wrong-colored item, the employee is required to 

leave the area and apply the correct apparel. The Production Supervisor makes this 

correction but does not document it.

o Corrective actions: If the problem was due to personnel from the peanut butter cookie 

production area entering the oatmeal/caramel chip cookie production area, these 

activities are corrective actions and are documented on the Checklist for Allergen CrossContact Controls. The Production Supervisor determines whether product may have 

been affected (i.e., whether product may have come in contact with peanut protein), and, 

if so, evaluates any affected dough and/or cookies for safety and prevents affected 

cookies from entering commerce by re-processing affected oatmeal or caramel chip 

cookie dough base as peanut butter cookies or diverting the affected oatmeal cookies or 

affected caramel chip cookies and/or dough to animal food.

11.13.3.4 Bakery B’s records for allergen cross-contact controls and 

associated preventive control management components

Bakery B maintains the following records:

• The written procedures for the allergen cross-contact controls, with the color-code 

designation for utensils, tools, and apparel; and

• The Checklist for Allergen Cross-Contact Controls used for documenting monitoring of 

utensils, tools, and apparel for the correct colors for the specific processing area. This 

“Checklist for Allergen Cross-Contact Controls” record also lists the specific nonconformances, if any, describes the corrective actions, and is initialed and dated by Bakery 

B’s PCQI to document the PCQI’s review of the record. 

11.13.4 Bakery B’s Label Controls

11.13.4.1 Bakery B’s label content controls and label management 

controls

In this example, Bakery B generates the labels for its cookies during production from an 

electronic file. As a result, Bakery B’s label content controls and label management controls are 

so inter-related that some records document monitoring/verification activities for both label 

content controls and label management controls.

11.13.4.1.1 Label content

Bakery B applies the following Label Content Procedures during development and production of 

product labels and receipt of ingredients:

• Label development stage: The Label Team develops a food allergen label specification by 

reviewing the ingredients listed in the recipe or formulation, and the components listed by 

suppliers for all ingredients, to identify all food allergens in each product and the food source 

of each allergenic ingredient or component.
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o The Label Team notes that the allergens contained in the ingredients are as follows:

 Oatmeal cookies: The allergenic ingredients are flour (wheat) and pasteurized liquid 

eggs. The names of the food sources are wheat and egg.

 Caramel chip cookies: The allergenic ingredients are flour (wheat) and pasteurized 

liquid eggs. The names of the food sources are wheat and egg.

 Peanut butter cookies. The allergenic ingredients are flour (wheat), pasteurized liquid 

eggs, and peanut butter (peanuts). The names of the food sources are wheat, egg, 

and peanuts.

o The Label Team notes that there are no additional allergenic components in other 

ingredients.

o An individual in the Label Team has responsibility for the food allergen label specification 

for the cookies. Because the labels are printed and applied during production (rather 

than printed in advance of production and stored until needed), that individual 

determines that the food allergen label specification does not need to include a feature 

such as color coding to help ensure that the correct labels are retrieved from storage. 

Therefore, the key label content features included in the food allergen label specification 

are the product name and the approach to naming the food sources of the ingredients 

that are (or contain) a food allergen. In choosing how to comply with the allergen labeling 

requirements of the FD&C Act, the individual considers that the name of the ingredient 

“flour” does not identify the food source of the allergen (i.e., wheat) and decides that the 

food allergen label specification for naming the food sources of the major food allergens 

that are ingredients in the cookies is to place a “Contains” statement for the food sources 

of all the food allergens in the cookies after the ingredient statement on the product label 

as follows:

 Oatmeal cookies: “Contains wheat and egg.”

 Caramel chip cookies: “Contains wheat and egg.”

 Peanut butter cookies: “Contains wheat, egg, and peanuts.”

o The Label Team Supervisor prints a sample of the product label to review the food 

allergen label specification for the product and documents approval by signing and 

dating the printed label. 

11.13.4.1.2 Label management

Production (staging): When a production run is scheduled, one individual in the Label Team 

selects the electronic file to be printed and sends the file to the Label Team Supervisor. The 

Label Team Supervisor confirms that the electronic file is the correct file for the product and 

then sends the file to the production printer where the labels will be generated when they are 

applied to the packages.

11.13.4.2 Bakery B’s monitoring/verification of label controls

Bakery B conducts the following activities to monitor/verify that its label controls are ensuring 

that its cookies are not misbranded under section 403(w) of the FD&C Act:
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11.13.4.2.1 Label content

• Before sending the electronic file for the production label to the production printer, the Label 

Team Supervisor verifies the content of the production label by reviewing the electronic file 

for the product label, to confirm that the product name and “Contains” statement in the 

electronic file match the approved food allergen label specification. The Label Team 

Supervisor sends the electronic file to the production printer, where the Production 

Supervisor will print a production label from the printer on the production line, paste that 

printed label onto the production sheet, and sign and date the production sheet next to the 

printed label.

41

• On a weekly basis, Bakery B’s PCQI reviews, initials, and dates the production sheets 

documenting the verification review of the content of the production label.

• Within a week of a problem that requires corrective action, Bakery B’s PCQI reviews the 

corrective action records, and initials and dates each of the records reviewed in the place 

marked “Verified by.”

11.13.4.2.2 Label management

• Electronic label generation during production: After the electronic file for production labels is 

sent to the printer on the production line, the Production Supervisor prints a label from the 

production printer, verifies that the product name and “Contains” statement on the labels 

match the approved food allergen label specification for the product, and documents this 

review by pasting the printed label onto the production sheet for cookies, signing and dating 

the production sheet next to the label. 

• Production of cookies (from packaging and code dating through case packing): The line 

operator verifies that the correct label is applied to each product through a visual check. This 

visual check occurs when the line is initially set up and each time newly printed labels are 

added to the line throughout the production run. The line operator records and initials the 

results of this visual check on the production sheet, along with the date and time of the 

check.

• On a weekly basis, Bakery B’s PCQI reviews, initials, and dates the records documenting:

o The verification that the correct electronic file has been sent to production; and

o The results of the visual check that the correct label is applied to each product.

• Within a week of a problem that requires a corrective action, Bakery B’s PCQI reviews the 

corrective action records, and initials and dates each of the records reviewed in the place 

marked “Verified by.”

41 In this example, a single record (i.e., the label printed from the production printer) documents 

verification activities for both the content of the product label and the selection of the correct electronic file 

for production. 
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11.13.4.3 Bakery B’s corrective actions/corrections for label controls

11.13.4.3.1 Corrective actions/corrections for label content controls

• Corrections: If the Label Team Supervisor determines that the label content (product name 

and/or “Contains” statement) does not match the approved food allergen label specification

before the electronic file is sent to the production printer, the Label Team Supervisor 

corrects the label content in the electronic file without creating a record of the correction.

• Corrective Actions: If the label content of production labels does not match the approved 

food allergen label specification and the problem is discovered only after packaged cookies 

have been labeled, Bakery B takes and documents the following corrective actions:

o Segregation of any affected products;

o Rework of affected products by manually transferring the trays of incorrectly labeled 

cookies to plastic-lined paper pouches and applying the correct label; 

o Investigation by the Production Manager and Label Team Supervisor to determine the 

root cause of the problem. As necessary to correct the problem and prevent it in the 

future, the Label Team modifies its procedures and arranges for re-training as 

appropriate; and

o Initiation of a recall of any product in commerce that is misbranded under section 403(w) 

of the FD&C Act.

11.13.4.3.2 Corrective actions/corrections for label management controls

• Corrections: If the Production Supervisor determines that an electronic file for the wrong 

label was sent to the production printer but the label has not been applied to product, the 

Production Supervisor follows up with the Label Team Supervisor to obtain the correct 

electronic file without creating a record of the correction.

• Corrective actions: If the wrong label is applied to any products, Bakery B takes and 

documents the following corrective actions:

o Segregation of any products that have the wrong label;

o Rework of affected products by manually transferring the trays of incorrectly labeled 

cookies to plastic-lined paper pouches and applying the correct label;

o Investigation by the Production Manager of the root cause of the problem. The 

Production Supervisor arranges for modification of the label management procedures, 

re-training of personnel, or both as appropriate; and

o Initiation of a recall of any product in commerce that is misbranded under section 403(w) 

of the FD&C Act.

11.13.4.4 Bakery B’s records for label controls and associated 

preventive control management components

11.13.4.4.1 Records for label content controls

Bakery B maintains the following records:

• Label Content Procedures.
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• The approved food allergen label specification, signed and dated by the Label Development 

Team Supervisor.

• The following records that are initialed and dated by the PCQI to document review of the 

records:

o The production label that is pasted onto the production sheet and signed and dated by 

the Production Supervisor; and

o Any corrective action records.

11.13.4.4.2 Records for label management controls

Bakery B maintains the following records:

• Label Management Procedures.

• The following records that are initialed and dated by the PCQI to document review of the 

records:

o The production label that is pasted onto the production sheet and signed and dated by 

the Production Supervisor; 

o The production sheet on which the line operator documents the results of the verification 

check that the correct label is being applied to the correct product at the beginning of 

each production run and each time newly printed labels are brought to the line during 

production; and

o The corrective action records.

11.13.5 Bakery B’s Supply-chain Controls

11.13.5.1 The ingredient with a food allergen hazard that requires a 

supply-chain-applied control

As discussed in section 11.13.2.3, based on initial discussions with potential suppliers of vegan 

caramel chips, Bakery B’s PCQI determined that the caramel chips have the potential for 

unintended milk presence as a result of allergen cross-contact by potential suppliers, because 

the potential suppliers produce non-vegan caramel, milk chocolate, and butterscotch chips that 

contain milk. 

11.13.5.2 The two vegan caramel chip processors that Bakery B 

evaluates as potential suppliers

Bakery B evaluates two vegan caramel chip processors as potential suppliers. The 

characteristics of these caramel chip processors are as follows:

• Caramel Chip Processor A uses dedicated processing lines (i.e., one processing line for 

production of caramel (and other) chips that contains milk and a different processing line for 

production of caramel (and other) chips that do not contain milk). Caramel Chip Processor A 
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does not provide an allergen advisory statement for caramel chips that it supplies as an 

ingredient to receiving facilities. 

• Caramel Chip Processor B uses product scheduling, scraping, and push-through cleaning of 

a processing line used to produce caramel chips containing milk before using that 

processing line to produce caramel chips that do not contain milk. Caramel Chip Processor 

B uses the push-through material as re-work in the production of caramel chip products that 

contain milk. During production, Caramel Chip Processor B routinely verifies the allergen 

cleaning by testing FCSs of the chip depositor for the presence of milk allergen, with repeat 

cleaning if necessary. Caramel Chip Processor B does not provide an allergen advisory 

statement for caramel chips that it supplies as an ingredient to receiving facilities. 

In this example, Bakery B will approve Caramel Chip Processor A and Caramel Chip Processor 

B as suppliers. In the remainder of this example, we refer to these processors as Supplier A and 

Supplier B, respectively.

11.13.5.3 Bakery B’s supplier approval and verification activities

To approve its suppliers, Bakery B:

• Asked each potential supplier to fill out a questionnaire related to:

o The supplier’s food allergen program (including the supplier’s CGMP measures, allergen 

cross-contact controls, and label controls); and 

o Whether the supplier provides an allergen advisory statement for the potential 

unintended milk presence in vegan caramel chips.

42

• Searched FDA’s “Supplier Evaluation Resources” web page (see Table 11-8) for information 

relevant to each supplier's compliance with applicable food safety regulations; 

• Reviewed a third-party audit provided by each supplier; and

• Tested several lots of vegan caramel chips from each potential supplier to confirm that the

caramel chips do not contain milk.

For ongoing verification of each approved supplier, Bakery B:

• Requires Supplier A to provide a Certificate of Conformance that the caramel chips are 

produced on a dedicated processing line each year and a third-party audit every three

years;

• Requires Supplier B to provide a third-party audit each year; and

• Samples and tests caramel chips from Supplier B quarterly. 

Bakery B’s PCQI reviews the Certificate of Conformance and the results of the audit and the 

analytical tests for the presence of milk in the caramel chips within a week of receipt and 

documents this review by signing and dating the Certificate of Conformance, results of the audit,

and the analytical tests.

42 In this example, neither supplier provides allergen advisory statements for its products. Bakery B’s 

supply-chain program specifies that Bakery B would ask any supplier that provides allergen advisory 

statements to provide the rationale for doing so.
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11.13.5.4 Bakery B’s corrective actions/corrections in the event of 

supplier non-conformance

• Corrections: If the results of an onsite audit raise questions about whether a supplier is 

controlling for unintended milk presence in the caramel chips, but it seems unlikely that

allergen cross-contact has occurred, Bakery B temporarily stops using the caramel chips 

from that supplier until the supplier addresses the questions raised by the audit. If it appears 

that the supplier is not able to address the questions in a timely fashion, Bakery B takes 

steps to approve a new supplier, relying in the meantime on the remaining supplier.

• Corrective actions: If the results of an onsite audit indicate that cross-contact is likely to have 

occurred or if the results of Bakery B’s sampling and testing demonstrate unintended milk 

presence in one or more lots of caramel chips: 

o Bakery B temporarily stops using the caramel chips from that supplier until the supplier 

can provide evidence that the problem has been corrected. If it appears that the supplier 

is not able to solve the problem in a timely fashion, Bakery B takes steps to approve a 

new supplier, relying in the meantime on the remaining supplier; and

o Bakery B’s PCQI evaluates caramel chip cookies that have been manufactured using 

caramel chips from the supplier for unintended milk presence, and evaluates whether 

cookies that have been released into commerce need to be recalled.

11.13.5.5 Bakery B’s records documenting its supply-chain controls 

Bakery B maintains the following records:

• The written supply-chain program required by 21 CFR 117.475(c)(1);

• Written procedures for the receipt of caramel chips (see 21 CFR 117.475(c)(4)), and a 

checklist documenting implementation of those procedures (see 21 CFR 117.475(c)(5));

• The following records that are initialed and dated by the PCQI to document review of the 

records:

o Documentation of the determination of the appropriate supplier verification activities for 

raw materials and other ingredients (see 21 CFR 117.475(c)(6)); 

o Documentation of the results of its search of FDA’s “Supplier Evaluation Resources” web

page (see Table 11-8) for each supplier as a supplier approval activity (see 21 CFR 

117.475(c)(3) and (6));

o The results of third-party audits for each supplier of caramel chips (see 21 CFR 

117.475(c)(7));

o The results of quarterly sampling and testing by Bakery B of caramel chips provided by 

Supplier B; and

o Records of any corrective actions (see 21 CFR 117.475(c)(16)).
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11.13.6 Summary of Bakery B’s Food Allergen Program

Appendix 11-3 summarizes Bakery B’s allergen cross-contact controls and label controls on the 

FSPCA’s Food Allergen Control Form (Form 2-H (Modified) from Appendix 2 of this guidance).

Appendix 11-3 also provides Bakery B’s: 

• Ingredient analysis to support both allergen cross-contact controls and label controls (Form 

2E (Modified) from Appendix 2 of this guidance); 

• Food allergen verification list to support label controls (Form 2F (Modified) from Appendix 2

of this guidance); and 

• Production line food allergen assessment to support allergen cross-contact controls (Form 

2G (Modified) from Appendix 2 of this guidance). 

11.14 References

Some of these references include a website address. FDA has verified these website 

addresses, as of the date the notice of availability for this document publishes in the Federal 

Register, but websites are subject to change over time.

Boyce JA, Assa'ad A, Burks AW, Jones SM, Sampson HA, Wood RA, Plaut M, Cooper SF, 

Fenton MJ, Arshad SH, Bahna SL, Beck LA, Byrd-Bredbenner C, Camargo CA Jr, 

Eichenfield L, Furuta GT, Hanifin JM, Jones C, Kraft M, Levy BD, Lieberman P, Luccioli 

S, McCall KM, Schneider LC, Simon RA, Simons FE, Teach SJ, Yawn BP, Schwaninger 

JM. 2010. Guidelines for the diagnosis and management of food allergy in the United 

States: report of the NIAID-sponsored expert panel. J Allergy Clin Immunol.126(6 

Suppl):S1-58.

Food and Agriculture Organization of the United Nations and World Health Organization. 2021. 

Ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens. 

Part 2: Review and establish threshold levels in foods of the priority allergens. Virtual 

meeting, 15 March – 2 April 2021. Summary and Conclusions. Available at 

https://www.who.int/news-room/events/detail/2021/03/15/default-calendar/ad-hoc-jointfao-who-expert-consultation-on-risk-assessment-of-food-allergens-part2-review-andestablish-threshold-levels-in-foods-of-the-priority-allergens 

Food and Agriculture Organization of the United Nations and World Health Organization. 2022. 

Ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens. 

Part 2: Review and establish threshold levels in foods of the priority allergens. Virtual 

follow-up meeting on milk and sesame. Summary and Conclusions. Available at 

https://www.who.int/news-room/events/detail/2021/03/15/default-calendar/ad-hoc-jointfao-who-expert-consultation-on-risk-assessment-of-food-allergens-part2-review-andestablish-threshold-levels-in-foods-of-the-priority-allergens

Grocery Manufacturers Association (GMA). 2009. Managing Allergens in Food Processing 

Establishments. Fourth Edition. Edited by WE Stone and KE Stevenson.

National Advisory Committee on Microbiological Criteria for Foods (NACMCF). 1998. Hazard 

Analysis and Critical Control Point Principles and Application Guidelines, Journal of 

Food Protection, 61: 1246-1259.
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Remington, BC, J Westerhout, MY Meima, WM Bloma, AG Kruizinga, MW Wheeler, SL Taylor, 

GF Houben, JL Baumert. 2020. Updated population minimal eliciting dose distributions 

for use in risk assessment of 14 priority food allergens. Food and Chemical Toxicology 

139: 111259. (https://doi.org/10.1016/j.fct.2020.111259) 

Taylor, SL and SL Hefle. 2001. Food Allergies and Other Food Sensitivities. Food Technology

55(9): 68-83.

11.15 Resources

The tables in this section are a compilation of resources that are available as of the date that we 

make this guidance available. We have verified the website addresses listed for these 

resources, as of the date that we make this guidance available, but websites are subject to 

change over time. In addition, the policies and recommendations in these resources can change 

over time. We recommend that you periodically review websites listing FDA’s CPGs, FDA’s 

Guidance for Industry, and the resources listed in Table 11-8 for new or modified policies and 

recommendations.

Table 11-6. Applicable FDA Compliance Policy Guides* 

CPG Link

CPG Sec. 555.250 Statement of Policy for 

Labeling and Preventing Cross-contact of 

Common Food Allergens. 2001

https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/cpg-sec-555250-statement-policy-labeling-andpreventing-cross-contact-common-food-allergens-new

CPG Sec 555.250 DRAFT: Major Food 

Allergen Labeling and Cross-contact. 

202343

https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/cpg-sec-555250-draft-major-food-allergen-labelingand-cross-contact 

*In addition to the specific link we provided, you can access FDA’s Manual of Compliance Policy Guides 

at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliancemanuals/manual-compliance-policy-guides. Chapter 5 addresses Food, Colors, and Cosmetics and is 

available at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/manualcompliance-policy-guides/chapter-5-food-colors-and-cosmetics.

43 In 2023, FDA issued for public comment a draft compliance policy guide entitled “CPG Sec. 555.250 

DRAFT: Major Food Allergen Labeling and Cross-contact” (88 FR 31507, May 17, 2023). When finalized, 

this draft CPG will replace existing guidance, in CPG Sec. 555.250 Statement of Policy for Labeling and 

Preventing Cross-contact of Common Food Allergens, for FDA staff on FDA’s enforcement policy 

regarding major food allergen labeling and cross-contact.
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Table 11-7. Applicable FDA Guidance for Industry* 

Guidance Link

Questions and Answers Regarding 

Food Allergens, Including the Food 

Allergen Labeling Requirements of 

the Federal Food, Drug, and 

Cosmetic Act (Edition 5). 2022. 

Guidance for Industry**

https://www.fda.gov/media/117410/download

Questions and Answers Regarding 

Food Allergens, Including the Food 

Allergen Labeling Requirements of 

the Federal Food, Drug, and 

Cosmetic Act (Edition 5). 2022. 

Draft Guidance for Industry*** 

https://www.fda.gov/media/163454/download

Human Food By-Products For Use 

As Animal Food: Draft Guidance 

for Industry #239*** 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-239-human-food-products-use-animal-food

*In addition to the specific link we provided, or if that link is no longer operative, you can access most of FDA’s Guidance for Industry applicable to 

human food at https://www.fda.gov/FoodGuidances. 

** In 2022, we announced the availability of both draft and final guidance for industry entitled “Questions and Answers Regarding Food Allergens, 

Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5) (87 FR 73561, November 30, 2022). 

These guidances are revisions of a currently issued guidance, entitled “Questions and Answers Regarding Food Allergens, Including the Food 

Allergen Labeling and Consumer Protection Act of 2004 (Edition 4).” The final guidance includes the questions and answers from the currently 

issued guidance that remain substantively unchanged. The draft guidance, when finalized, will explain FDA’s current thinking on a number of 

issues related to the labeling of food allergens, including requirements in both FALCPA and the FASTER Act. 

*** A draft guidance, when finalized, will represent FDA’s current thinking on the specified topic.

Table 11-8. Additional Resources 

Source Resource Title Resource Link

3-A Sanitary 

Standards, 

Inc.

3-A Sanitary 

Standards and 

Accepted 

Practices* 

https://www.3-a.org/
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Source Resource Title Resource Link

American 

Meat 

Institute

AMI Fact Sheet. 

Sanitary 

Equipment 

Design. 2014.

https://www.meatinstitute.org/index.php?ht=a/GetDocumentAction/i/11006

European 

Hygienic 

Engineering 

and Design 

Group 

(EHEDG) 

EHEDG 

Guidelines Doc 

8. Hygienic 

Design

Principles. Third 

Edition. 2018.

https://www.ehedg.org/guidelines/

FDA Firm/Supplier 

Evaluation 

Resources for 

FSMA Rules

https://www.fda.gov/food/food-safety-modernization-act-fsma/firmsupplier-evaluation-resources-fsma-rules

FDA Food 

Allergens/GlutenFree Guidance 

Documents & 

Regulatory 

Information

https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/food-allergens-and-glutenfree-guidance-documents-and-regulatory-information

FDA Industry 

Guidance For 

Recalls

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/industry-guidance-recalls

FDA Label 

Declaration of 

Allergenic 

Substances in 

Foods; Notice to 

Manufacturers. 

1996

http://wayback.archiveit.org/7993/20171114013857/https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/ucm106546.htm

FDA FSMA Final Rule 

on Sanitary 

Transportation of 

Human and 

Animal Food

https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-sanitary-transportation-human-and-animal-food
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Source Resource Title Resource Link

Schmidt, RH 

and DJ 

Erickson, 

Food 

Science and 

Human 

Nutrition 

Department, 

Florida 

Cooperative 

Extension 

Service, 

Institute of 

Food and 

Agricultural 

Sciences, 

University of 

Florida

Sanitary Design 

and Construction 

of Food 

Equipment. 

2005.

https://ucfoodsafety.ucdavis.edu/sites/g/files/dgvnsk7366/files/inline-files/26502.pdf

*Available for purchase.
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Appendix 11-1 CGMP Measures to Prevent Allergen Cross-Contact

11-1.A CGMP Measures Are Part of Your Food Allergen Program

As noted in section 11.1, your hazard analysis should consider how your CGMP measures 

prevent allergen cross-contact, and the preventive controls that you establish and implement to 

address a food allergen hazard should complement and enhance your CGMP measures for 

preventing allergen cross-contact. To help you do so, in this Appendix we provide 

recommendations for measures you can take to comply with the CGMP requirements in 21 CFR 

part 117, subpart B, to prevent allergen cross-contact. As noted in section 11.3, you should 

design your food allergen program to prevent allergen cross-contact between foods with 

different food allergen profiles. 

Although the CGMPs do not specify that you take corrective actions if you identify a failure of 

your CGMP measures to prevent allergen cross-contact, we recommend that you implement 

corrections or corrective actions as necessary and appropriate to ensure that the CGMP 

measures that are part of your food allergen program are operating as intended to prevent 

allergen cross-contact. An example of a correction is re-cleaning equipment that is not visibly 

clean before beginning production. Examples of corrective actions are re-training personnel who 

implement the CGMP measures and revising applicable procedures if the procedures do not 

prevent allergen cross-contact as intended.

11-1.B CGMP Measures to Prevent Allergen Cross-Contact by Personnel

Examples of CGMP measures that you can implement to prevent allergen cross-contact by 

personnel are:

• Provide personnel who work in direct contact with raw materials or other ingredients that are 

(or contain) a food allergen, or who work on a production line for a food product that 

contains a food allergen, with aprons, smocks, uniforms, or other appropriate types of clean,

washable outer garments. When practical for your operation, an additional CGMP measure 

is for these outer garments and other apparel (such as hairnets) to be dedicated (e.g., to the 

production of products with distinct food allergen profiles) and distinguishable (e.g., through

a color-coding system).

• Assign employees to work exclusively with foods containing the same food allergen profile. 

Alternatively, establish procedures for employees to change apparel when they move 

between areas that are processing foods with different food allergen profiles. When practical

for your operation, an additional CGMP measure is to avoid production assignments that 

would require personnel to move back and forth, during the same shift, between a 

processing line that contains a food allergen and a different processing line for food that has 

a different food allergen profile. 

• Provide disposable gloves for use by personnel who directly handle foods containing food 

allergens and direct those personnel to discard the gloves in a covered waste bin

immediately after use. Alternatively, emphasize the importance of washing hands after 

working with foods that are, or contain, a food allergen and of maintaining reusable gloves in 

an intact, clean, and sanitary condition.
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• Develop traffic patterns that restrict the movement of personnel (including personnel with 

responsibilities for production, maintenance, and clerical activities) between areas that are 

processing foods with different food allergen profiles.

• Provide separate break areas for use by personnel who work in processing areas with 

different food allergen profiles when doing so is practical for your operation. Alternatively, 

provide an apparel area, at the entrance to the processing area for foods that are, or 

contain, food allergens, where personnel obtain outer garments to be worn in the processing 

area and return the outer garments when they leave the area (e.g., for breaks or at the end 

of the shift), or instruct personnel on where to leave outer garments when they leave the 

production area.

In addition to these CGMP measures to prevent allergen cross-contact by personnel, we 

recommend that you make visitors aware of food allergen practices in the plant to prevent 

allergen cross-contact due to the actions of the visitors.

The sections of part 117 that are relevant to the recommendations in this chapter regarding 

personnel are 21 CFR 117.10(b)(1), 117.10(b)(3), 117.10(b)(5), and 117.10(b)(9).

11-1.C CGMP Measures for the Design and Construction of the Plant to 

Prevent Allergen Cross-Contact

When building a new plant or remodeling an existing plant, we recommend that you incorporate 

features in overall plant layout and design that will minimize the potential for allergen crosscontact and facilitate cleaning of equipment. When doing so is not practical (e.g., due to 

limitations in the design of an existing plant), we recommend that you place increased emphasis 

on CGMP measures for sanitary operations, equipment and utensils, storage and handling of 

raw materials and other ingredients, and processing operations.

Examples of features that you can incorporate in the design and construction of the plant to 

prevent allergen cross-contact are:

• Separation in space between areas processing foods with different food allergen profiles, 

such as by a dedicated plant, section of a plant, or processing line (e.g., separated by 

permanent or temporary doors and full or partial walls);

• Use of enclosed equipment or processing lines (e.g., closed pipes, tanks, pumps, heat 

exchangers, and fillers) when practical and appropriate. Alternatively, configuration of open 

production lines so they do not cross over to minimize the potential for an allergencontaining food to fall onto a line containing food with a different food allergen profile. 

Another alternative is to install barriers such as pans and shields at the crossover points.

• Use of valves to physically separate ingredients with different food allergen profiles in 

processing equipment or lines. When using valves, we recommend that you:

o Ensure that all valves are clearly marked; and

o Clean and inspect valves routinely for potential leaks.

• Use of air flow controls to prevent airborne particulate matter that is, or contains, a food 

allergen from being brought into areas that do not use that food allergen. Examples of such 

air flow controls are a microbiological air filtration system and a positive air pressure 

environment in the packaging area.
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• Use of traffic patterns that that do not cross over open production lines and that restrict the 

movement of equipment, raw materials and other ingredients, WIP, rework, and finished 

product between areas in which foods with different food allergen profiles are exposed to the 

environment in the plant. 

• Creation of a buffer room or clean area between areas handling foods with different food 

allergen profiles.

The sections of part 117 that are relevant to the recommendations in this chapter regarding the 

design and construction of the plant are 21 CFR 117.20(b)(2), 117.20(b)(4), and 117.20(b)(6).

11-1.D CGMP Measures for Sanitary Operations to Prevent Allergen CrossContact

Examples of CGMP measures that you can implement to prevent allergen cross-contact during 

cleaning operations are:

• Establish and implement cleaning procedures that are tailored to the removal of allergenic 

food residues from your equipment and utensils based on the:

o Nature of the food or ingredient; 

o Type of food residue that is being removed (e.g., liquid, paste, or powders); 

o Type of FCS (e.g., stainless steel, rubber, or plastic);

o Nature of the cleaning equipment (e.g., CIP or manual); and 

o Cleaning options (detergents for wet operations, vacuums and brushes for dry 

operations).

• Clean equipment and utensils in a manner that protects against allergen cross-contact.

Examples of how to do so are:

o Using freshly prepared cleaning solutions (rather than reusing cleaning solutions that

could cause recontamination of surfaces with allergenic food residue);

o Using vacuums, rather than compressed air or grit blasting, for removing dry food 

residue from difficult-to-clean areas, because compressed air and grit blasting can 

disperse food allergen residues from one area to another. Alternatively, if vacuums 

cannot remove such residues, you could disassemble the equipment to enable you to 

remove such residues. If you need to use compressed air or grit blasting (e.g., if 

vacuums cannot remove such residues and it is not practical to disassemble equipment 

for cleaning food residue), you should take precautions to contain food residues that are 

forcefully removed by the compressed air or grit blasting; and

o Using low pressure water hoses, rather than high pressure water hoses, for removing 

food residues from wet processing areas, because high pressure water hoses could 

spread and aerosolize food allergen residues during cleaning.

• Clean bins, totes, and containers used for ingredients that are, or contain, a food allergen as 

soon as possible after being emptied.

• Dismantle equipment, as appropriate, to allow for manual cleaning.

• Inspect equipment after each cleaning to determine whether it is visibly clean, and 

periodically confirm the results of the visible inspection through periodic (e.g., quarterly) 
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analytical tests (whether general tests for any food residue, or specific tests for residues of 

food allergens).

The sections of part 117 that are relevant to the recommendations in this chapter regarding

sanitary operations are 21 CFR 117.35(a), 117.35(c), and 117.35(d). 

11-1.E CGMP Measures on Equipment and Utensils to Prevent Allergen 

Cross-Contact

Examples of CGMP measures that you can implement to prevent allergen cross-contact from 

equipment and utensils are:

• Purchase or design equipment with hygienic design features to prevent the accumulation of 

food residues, to allow easy access for dismantling, cleaning, and inspecting equipment, 

and (for liquid transfer systems) to minimize the potential for allergen cross-contact through 

cross connections or pressure differentials (e.g., through use of “make or break” 

connections to facilitate disconnecting CIP lines during production). Resources that you 

could adapt to help you do so are available online or are available for purchase (see Table 

11-8). Although these publications are directed to sanitary design of equipment to prevent 

contamination of food from pathogenic microorganisms, the same principles generally apply 

to the prevention of allergen cross-contact. 

• When repairing or maintaining equipment, ensure that welds are smooth; replacement 

materials are easily cleanable; seals and hoses do not contain cracks; and “dead ends” or 

other areas where pockets of materials can accumulate are eliminated.

• Provide shielding, permanent and/or temporary partitions, covers, and catch pans to protect 

exposed unpacked product from allergen cross-contact.

• Provide physical containment of dry ingredients by partially or completely covering specific 

equipment, such as conveying equipment, hoppers, storage silos, shakers, and size 

graders.

• Dedicate distinguishable (e.g., through color-coding) utensils and tools for processing lines 

with different food allergen profiles, when practical for your operation. Alternatively, place 

increased emphasis on sanitary operations, such as by visually inspecting equipment and 

tools that are shared between processing lines for products with different food allergen 

profiles for food residues that could contain food allergens.

The sections of part 117 that are relevant to the recommendations in this chapter regarding 

equipment and utensils are 21 CFR 117.40(a)(1) and (6) and 117.40(b).

11-1.F CGMP Measures for Raw Materials and Other Ingredients, and for 

Manufacturing Operations, to Prevent Allergen Cross-Contact

11-1.F.1 CGMP measures for raw materials and other ingredients to 

prevent allergen cross-contact

Examples of CGMP measures that you can implement to prevent allergen cross-contact during 

receipt and storage of raw materials and other ingredients are:
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• Review all labels on, and documents accompanying, shipments of raw materials or other 

ingredients (including minor ingredients such as spice blends) to confirm that the raw 

material or other ingredient contains only the expected food allergen(s).

• Inspect allergen-containing raw materials and other ingredients upon receipt to ensure that 

the containers are intact and that the contents have not leaked or spread. If containers have 

leaks, tears, or other defects, inspect nearby containers for evidence of allergen crosscontact. Either reject (or properly dispose of) raw materials and other ingredients when a 

container is not intact or there is evidence of allergen cross-contact, or handle damaged 

containers in a manner that prevents allergen cross-contact. For example, you could store 

damaged containers in a separate location, place a damaged container inside another 

container, or move the contents of the damaged container to a different container, with 

appropriate identification of any new containers that you use. You should not move 

damaged containers into a production area unless leakage of allergen-containing raw 

materials and other ingredients has been contained.

• Clearly identify allergen-containing raw materials and other ingredients using a system that 

adequately distinguishes between raw materials and other ingredients with different food 

allergen profiles to alert personnel that these materials are subject to special precautions 

and handling procedures throughout the plant. An example of such a system is color-coding 

– e.g., through use of color-coded stickers/tags, placards, or shrink-wrap, with a specific 

color dedicated to each of the major food allergens and a system (such as a chart displayed 

at multiple locations in the plant) for alerting personnel to the assigned colors.

44 Another 

example of such a system is the use of distinctive pallets, totes, or bins dedicated to specific 

food allergens. 

• Establish and implement measures to ensure that raw materials and other ingredients that 

are received in bulk or food not completely enclosed by a container, including those 

delivered by railcar or tanker, have been transported and are being transferred in a manner 

that does not result in allergen cross-contact.

45 Examples of such measures are verification 

of tanker and/or railcar cleaning (e.g., hopper, boxcar, tanker, wash-tags), prior load 

information, and cleaning and sanitizing vehicles and transportation equipment. You should 

reject the shipment if there is evidence that food has not been protected from allergen crosscontact.

• Segregate allergen-containing raw materials and other ingredients from raw materials and 

other ingredients that do not contain allergens – e.g., in a dedicated storage room or area of 

the plant, or in separate bays or areas of a storage room. If a dedicated storage room or 

area is not available, we recommend that you store raw materials and other ingredients that 

contain allergens below those that do not contain allergens to prevent allergen cross-contact 

in the event of a spill or leak.

44 If your plant uses a color-coding system for purposes other than identification of food allergens, you 

should take steps to prevent confusion between the color-coding systems.

45 Our regulations (in 21 CFR Part 1, Subpart O) for Sanitary Transportation of Human and Animal Food

establish requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in 

transporting human and animal food to use sanitary practices to ensure the safety of the food. The goal of 

the regulations is to prevent practices during transportation that create food safety risks, such as failure to 

properly refrigerate food requiring temperature control for safety, inadequate cleaning of vehicles between 

loads, and failure to properly protect food. For more information see our webpage “FSMA Final Rule on 

Sanitary Transportation of Human and Animal Food” (see Table 11-8). 
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• Use secure, closable containers to store allergen-containing raw materials and other 

ingredients.

• When receiving or using bulk storage tanks or silos:

o Use techniques such as visual identifiers (e.g., stickers or tags), computerized 

verification checks, lockouts over valve openings, and employee inspection and sign-off 

on a valve and tank set-up to prevent mix-ups that could result in allergen cross-contact; 

and

o Clean bulk storage tanks or silos used to store an allergen-containing raw material or 

other ingredient before using the bulk storage tanks or silos for a raw material or other 

ingredient that has a different food allergen profile.

• Use containers that are movable on their own, rather than containers that need to be moved 

with handling equipment such as dollies, forklifts, or pallet jacks, for allergen-containing raw 

materials and other ingredients, whenever practical. Alternatively, clean the handling 

equipment after moving allergen-containing raw materials and other ingredients. You should 

take care to avoid damage to containers or the spread of allergens within your plant from 

transporting or lifting devices.

The sections of part 117 that are relevant to the recommendations in this chapter regarding raw 

materials and other ingredients are 21 CFR 117.80(b)(1), 117.80(b)(5), 117.80(b)(7), and 

117.80(b)(8).

11-1.F.2 CGMP measures for manufacturing operations to prevent 

allergen cross-contact

Examples of CGMP measures that you can implement to prevent allergen cross-contact during 

manufacturing operations are:

• Implement production scheduling to separate by time the manufacture of products with 

different food allergen profiles. For example, you could produce the foods in a sequence 

whereby the food with no allergen or the fewest allergens is produced first and the food with 

the most allergens is produced last. As another example, you could cluster runs of products 

containing the same food allergen profile to reduce the number of changeovers.

• Add allergenic ingredients as late in the production process as possible, and as far 

downstream as possible in the processing line (e.g., closest to the filling and packaging 

equipment), to minimize the amount of equipment in the production area that comes in 

contact with the allergen.

• Stage allergen-containing raw materials and other ingredients in designated areas as close 

as possible to the production area before opening, weighing, or transferring them in covered 

or closed containers to the processing line.

• Add raw materials and other ingredients that are, or contain, a food allergen in a manner 

that minimizes the potential for unintentional dispersion by dust. For example, you could 

minimize the formation and dispersion of dust by adding liquid ingredients to mixers at the 

same time as powders, using dust collection systems (e.g., local exhaust, ventilation 

systems and/or vacuum systems), controlling surrounding dust sources, and/or covering 

equipment.

• Immediately clean up spills that contain food allergens. 
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• Place special emphasis on the control of WIP and re-work that contain food allergens. 

Examples of how to control WIP and rework to prevent allergen cross-contact are:

o Clearly identify WIP and rework (including the name of the WIP/rework, all food 

allergens present in the WIP/rework, the date of manufacture, which production line the 

materials will be added to and, where known, the date the rework is to be used) and

store them in sturdy containers with secure covers in designated, clearly marked areas. 

Use interior disposable plastic liners where appropriate.

o Assemble all WIP and rework for a specific batch of product in a dedicated staging area 

before transferring the WIP/rework to the processing line.

o Implement a rework policy for rework to be added back to same finished product (i.e., 

“exact into exact”) whenever practical. Alternatively, add rework to another product with 

the same food allergen profile.

o Use allergen-containing WIP and rework as soon as possible to minimize the potential 

for the rework to be incorporated into the wrong product.

• Use allergen-specific testing procedures where necessary and when possible to identify 

sanitation failures or possible allergen cross-contact.

• Place waste materials that contain food allergens (e.g., spills, defective and unusable 

products, used ingredient packaging) in covered collection bins, totes, or containers that are 

identified as holding allergen-containing waste.

The sections of part 117 that are relevant to the recommendations in this chapter regarding 

manufacturing operations are 21 CFR 117.80(a)(5), 117.80(c)(1), 117.80(c)(5), 117.80(c)(6), 

117.80(c)(7), 117.80(c)(10), 117.80(c)(12), and 117.80(c)(13).

11-1.G CGMP Measures for Warehousing and Distribution to Prevent 

Allergen Cross-contact

Examples of CGMP measures that you can implement to prevent allergen cross-contact during 

warehousing and distribution are:

• Hold food in sealed packages or closed containers.

• When moving containers of allergen-containing products using handling equipment such as 

dollies, forklifts, or pallet jacks, take care to avoid damage to packaging that could result in 

food allergen residues on packages of foods that do not contain that food allergen. (Opening 

the package could result in transfer of food allergens on the package exterior to the food 

inside.)

• Clean up spills or leaks from damaged containers of allergen-containing products as soon 

as they occur.

The section of part 117 that is relevant to the recommendations in this chapter regarding 

warehousing and distribution is 21 CFR 117.93.
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Appendix 11-2 Summary of Dessert Manufacturer A’s Food Allergen 

Controls and Associated Preventive Control Management 

Components

FORM 2-D (Modified) Allergen Cleaning Procedures

PAGE _________

PRODUCTS: Raspberry sorbet, vanilla ice cream, vanilla frozen custard, and vanilla frozen 

custard with almonds

PLANT NAME: _Dessert Manufacturer A __ADDRESS: _______________________________

ISSUE DATE: (mm/dd/yy)____________SUPERSEDES: (mm/dd/yy)__________________

Allergen Cleaning

Item Applicable Information

Location Production Line

Purpose Remove all residues of allergen-containing food and ingredients

Frequency - After production of vanilla frozen custard with almonds, when production sequence is 

normal as follows: (1) raspberry sorbet; (2) vanilla ice cream; (3) vanilla frozen custard; (4) 

vanilla frozen custard with almonds; and

- Any time the production sequence does not follow the normal sequence 

Who Provider of food hygiene services and Sanitation Supervisor

Procedure Allergen cleaning procedure

Monitoring - During each cleaning procedure, the Sanitation Supervisor uses the allergen cleaning 

checklist to document monitoring of each step in the cleaning procedure and note any 

corrections.

- Before each production run of raspberry sorbet, the Sanitation Supervisor conducts and 

documents a pre-operational visual inspection of applicable equipment and utensils as 

monitoring that they are visibly clean.

Verification - After the equipment has been cleaned and visually inspected, the Sanitation Supervisor 

uses an ATP bioluminescence swab test or a protein swab test to verify that the line is clean

and notes the results on the allergen cleaning checklist. 

- On a quarterly basis, and whenever there is a change in the cleaning procedure, a QA 

technician verifies the visual inspection by conducting allergen-specific analytical tests before 

a production run of raspberry sorbet that follows a run of vanilla frozen custard with almonds

and keeps the analytical test results as a record. 

- On a weekly basis, the PCQI reviews the allergen cleaning checklists, including results of 

ATP bioluminescence swab tests or protein swab tests, as verification that all equipment and 

utensils have been cleaned prior to production, and documents that record review by 

initialing and dating the allergen cleaning checklists. 

- On a weekly basis, the PCQI reviews pre-operational visual inspection records and 

documents that record review by initialing and dating the records. 

- Within a week of any allergen-specific analytical tests to verify the visual inspection, the 

PCQI reviews the results of the analytical tests as verification, and documents that record 

review by initialing and dating the results. 

- Within a week of a problem that requires corrective action, the PCQI reviews the corrective 

action records, and initials and dates each of the records reviewed in the place marked 

“Verified by.”
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 90

Item Applicable Information

Corrections - If the Sanitation Supervisor observes, during monitoring, that a step in the allergen cleaning 

procedure has not been properly implemented, the Sanitation Supervisor directs personnel to 

repeat the full cleaning procedure before beginning the next production run and notes this 

action on the allergen cleaning checklist. 

- If the ATP or protein swab tests indicate that the equipment has not been adequately 

cleaned, the Sanitation Supervisor directs personnel to repeat the full cleaning procedure 

and notes this action on the allergen cleaning checklist. 

Corrective actions If a routine analytical test detects unintended allergen presence in raspberry sorbet, or if a 

consumer who has an allergy to egg, milk, or almonds reports an allergic reaction to 

raspberry sorbet:

- If the problem was identified through a consumer report of an allergic reaction, 

Manufacturer A conducts product testing to confirm the unintended allergen and, if allergen 

cross-contact has occurred, determine the extent of the problem (e.g., number of affected 

lots). 

- The Production Manager conducts a root cause investigation to try to determine whether:

- Allergen cleaning procedures were not properly implemented; or 

- The allergen cleaning procedures are not effective.

- When appropriate based on the root cause of the problem, the Production Supervisor:

- Re-trains sanitation managers/personnel;

- Revises the allergen cleaning procedures; 

- Appropriately disposes of impacted lots of raspberry sorbet that have not yet been 

distributed; and

- Recalls affected lots of raspberry sorbet that are in commerce and are adulterated 

under section 402(a)(4) of the FD&C Act due to allergen cross-contact.

Records - An SSOP (with procedures for cleaning food-contact surfaces and forms to communicate 

the written procedures and document their use, for monitoring/verification and for 

corrections/corrective actions); 

- The following records that are dated and initialed by the PCQI:

- The allergen cleaning checklist for each cleaning cycle;

- Pre-operational visual inspection records 

- A record of the results of any analytical test conducted to confirm the results of visual

inspection; and

- Any corrective action records.

Verification: (signature or initials)_____________________Date: ________________________
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 91

FORM 2-E (Modified) FOOD ALLERGEN INGREDIENT ANALYSIS

PAGE _________

PRODUCTS: Raspberry sorbet, vanilla ice cream, vanilla frozen custard, and vanilla frozen 

custard with almonds

PLANT NAME: _Dessert Manufacturer A __ADDRESS: _______________________________

ISSUE DATE: (mm/dd/yy)____________SUPERSEDES: (mm/dd/yy)__________________

Food Allergens in Ingredient Formulation or in Allergen Advisory Statements: Vanilla ice 

cream

Raw Material 

Name Supplier

Egg

Milk

Soy

Wheat

Tree Nut (almond)

Peanut

Fish (market name)

Shellfish (market 

name)

Sesame

Food Allergens in 

Allergen Advisory

Statements

Cream Creamery A 

and Creamery 

B 

X 

Milk powder Powdered Milk 

Manufacturer C 

and Powdered 

Milk 

Manufacturer D

X 

Food Allergens in Ingredient Formulation or in Allergen Advisory Statements: Vanilla 

frozen custard

Raw 

Material 

Name Supplier

Egg

Milk

Soy

Wheat

Tree Nut (almond)

Peanut

Fish (market name)

Shellfish (market 

name)

Sesame

Food Allergens in 

Allergen Advisory

Statements

Cream Creamery A and 

Creamery B X 

Milk powder Powdered Milk 

Manufacturer C 

and Powdered 

Milk Manufacturer 

D 

X 
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 92

Raw 

Material 

Name Supplier

Egg

Milk

Soy

Wheat

Tree Nut (almond)

Peanut

Fish (market name)

Shellfish (market 

name)

Sesame

Food Allergens in 

Allergen Advisory

Statements

Pasteurized 

liquid eggs

Egg 

Establishment E 

and Egg 

Establishment F

x 

Food Allergens in Ingredient Formulation or in Allergen Advisory Statements: Vanilla 

frozen custard with almonds

Raw 

Material 

Name Supplier

Egg

Milk

Soy

Wheat

Tree Nut (almond)

Peanut

Fish (market name)

Shellfish (market 

name)

Sesame

Food Allergens in 

Allergen Advisory

Statements

Cream Creamery A and 

Creamery B X 

Milk powder Powdered Milk 

Manufacturer C 

and Powdered Milk 

Manufacturer D

X 

Pasteurized 

liquid eggs

Egg Establishment 

E and Egg 

Establishment F

x 

Roasted, 

chopped 

almonds

Almond Handler G 

and Almond 

Handler H

x 
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 93

FORM 2-F (Modified) FOOD ALLERGEN LABEL VERIFICATION LIST

PAGE _________

PRODUCTS: Raspberry Sorbet, vanilla ice cream, vanilla frozen custard, and vanilla frozen 

custard with almonds

PLANT NAME: _Dessert Manufacturer A __ADDRESS: _______________________________

ISSUE DATE: (mm/dd/yy)____________SUPERSEDES: (mm/dd/yy)__________________

Product Allergen Statement [In Ingredient List]

Raspberry sorbet Not applicable

Vanilla ice cream Milk powder

Vanilla frozen custard Milk powder, eggs

Vanilla frozen custard with almonds Milk powder, eggs, almonds
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 94

FORM 2-G (Modified) PRODUCTION LINE FOOD ALLERGEN ASSESSMENT

PAGE _________

PRODUCTS: Raspberry Sorbet, vanilla ice cream, vanilla frozen custard, and vanilla frozen 

custard with almonds

PLANT NAME: _Dessert Manufacturer A __ADDRESS: _______________________________

ISSUE DATE: (mm/dd/yy)____________SUPERSEDES: (mm/dd/yy)__________________

Production Line Assessment

Product Name

Production 

Line 

Egg

Milk

Soy

Wheat

Tree Nut (almond)

Peanut

Fish (market 

name)

Shellfish (market 

name)

Sesame

Raspberry sorbet Line A

Vanilla ice cream Line A x

Vanilla frozen custard Line A X x

Vanilla frozen custard with 

almonds

Line A X x x
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 95

FORM 2-H (Modified) FOOD ALLERGEN CONTROLS

PAGE _________

PRODUCTS: Frozen desserts________________________________________________

PLANT NAME: _Dessert Manufacturer A__ADDRESS: _____________________________

ISSUE DATE: (mm/dd/yy)____________SUPERSEDES: (mm/dd/yy)__________________

ALLERGEN CONTROL STEP: _Label content: Correct food allergen label specification____

HAZARD(S): __Food allergens (milk, eggs, almonds)________________________________

Criterion

What to 

Monitor

How to 

Monitor

Frequency of 

Monitoring

Who 

Monitors

Corrective Action/ 

Corrections Verification Records

Correct food 

allergen label 

specification 

for:

- The product 

name and 

Ingredient 

statement on 

tubs of frozen 

dessert; 

- The product 

name on lids 

for frozen 

dessert; and

- The color on 

the edge of 

the product 

tubs and lids

N/A – Dessert 

Manufacturer 

A classifies 

its activity as 

verification

N/A N/A N/A - Correction (not 

documented): Reject lots 

of incorrect tubs and lids 

and follow up with tub/lid 

manufacturer

- Corrective action 

(documented): If the 

inaccurate label content is 

not discovered until after 

the product is packaged: 

- Segregate incorrectly 

packaged products; 

- Rework or discard 

product as 

applicable; 

- Investigate root 

cause and modify 

procedures or retrain personnel as 

applicable; and 

- Recall if necessary

- Upon receipt of the tubs and lids, QA 

personnel:

 - Check that the product name and 

ingredient statement on the label 

pre-printed on the tubs, the

product name on the label preprinted on the lids, and the color 

on the edges of the tubs and lids, 

match the approved food allergen 

label specification;

- Document this verification review 

on a Label Review Form included 

in the Label Content Procedures 

and sign and date the form.

- On a weekly basis, the PCQI reviews, 

initials, and dates the Label Review 

Forms documenting the verification 

review of the product tubs and lids.

- Within a week of any corrective 

actions, the PCQI reviews, initials, and 

dates the corrective action records.

- Label Content Procedures

- The approved food 

allergen label specification, 

signed and dated by the 

Label Coordinator 

- The following records, 

initialed and dated by the 

PCQI:

- Label Review Forms 

documenting the 

verification review of 

the product tubs and 

lids; and

- Any corrective action 

records.
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 96

FORM 2-H (Modified) FOOD ALLERGEN CONTROLS

PAGE _________

PRODUCTS: Frozen desserts________________________________________________

PLANT NAME: _Dessert Manufacturer A___ADDRESS: ____________________________

ISSUE DATE: (mm/dd/yy)__________SUPERSEDES: (mm/dd/yy)_____________________

ALLERGEN CONTROL STEP: _Label management: Correct tub/lid brought to staging and correct tub/lid used in packaging

HAZARD(S): __Food allergens (milk, eggs, almonds)________________________________

Criterion

What to 

Monitor How to Monitor Frequency of Monitoring

Who 

Monitors Corrective Action/ Correction Verification Records

Storage of 

tubs and lids 

in boxes on 

pallets with a 

sticker 

containing the 

product name 

and carton 

size on the 

outside of the 

box

Storage of 

tubs and lids 

at receipt and 

following 

production

Visual observation Weekly QA 

personnel

Corrections (documented on a 

Storage Record for Label 

Controls): Return any 

incorrectly stored tubs or lids to 

the correct storage location

On a weekly basis, 

the PCQI reviews, 

initials, and dates 

Storage Record for 

Label Controls 

documenting 

monitoring storage 

of tubs or lids and 

associated 

corrections

- Storage Record for 

Label Controls

 

Check that tub 

brought to the 

staging area 

has the 

correct color 

on the edge of 

the tub, and 

that the lid 

brought to the 

staging area 

has the 

correct 

product name 

and color

The staging 

check of the 

product tub 

and lid

- Visually observe that the 

top edge of the tub and lid 

have the correct color 

At the beginning 

of packaging and 

when new tubs or 

lids are brought 

to the line

Line 

operator

Correction (documented): 

Remove incorrect tubs or lids 

from the line, return to storage, 

and obtain the correct tub and 

lid. 

On a weekly basis, 

the PCQI reviews, 

initials, and dates 

any production 

sheets 

documenting the 

staging checks, 

including when an 

incorrect tub or lid 

is on the line at the 

beginning of 

production 

- Label Management 

Procedures, including 

the procedures for 

monitoring the staging 

check of the product 

tub and lid

- The production 

sheets documenting 

the staging checks, 

initialed and dated by 

the line operator (and 

the PCQI). 
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 97

Criterion

What to 

Monitor How to Monitor Frequency of Monitoring

Who 

Monitors Corrective Action/ Correction Verification Records

Use of the 

correct tub 

during 

packaging

That the 

correct tub is 

being used 

during 

packaging

- Manually use a barcode 

scanner

When the line is 

set up and at 

hourly intervals 

throughout the 

production run

Line 

operator

Corrective action

(documented): 

- Segregate incorrectly 

packaged products; 

- Rework or discard product 

as applicable; 

- Investigate root cause 

and modify procedures or 

re-train personnel as 

applicable; and 

- Recall if necessary

- On a weekly 

basis, the PCQI 

reviews, initials, 

and dates 

production sheets 

documenting 

results of the 

barcode scanning 

of the tubs

- Within a week of 

any corrective 

actions, the PCQI 

reviews, initials, 

and dates the 

corrective action 

records.

The following records, 

initialed and dated by 

the PCQI:

- The production 

sheets with the 

results of the 

barcode scanner 

and verification 

check that 

unused tubs and 

lids are put in 

appropriately 

stickered boxes; 

and

- Any corrective 

actions
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 98

Appendix 11-3 Summary of Bakery B’s Food Allergen Controls and 

Associated Preventive Control Management Components

FORM 2-E (Modified) FOOD ALLERGEN INGREDIENT ANALYSIS

PAGE _________

PRODUCTS: Oatmeal cookies, caramel chip cookies, and peanut butter cookies

PLANT NAME: _Bakery B ____ADDRESS: _____________________________________

ISSUE DATE: (mm/dd/yy)____________SUPERSEDES: (mm/dd/yy)__________________

Food Allergens in Ingredient Formulation or in Allergen Advisory Statements: Oatmeal 

cookies

Raw Material 

Name Supplier

Egg

Milk

Soy

Wheat

Tree Nut (market 

name) 

Peanut

Fish (market name)

Shellfish (market 

name)

Sesame

Food Allergens in 

Allergen Advisory

Statements

Flour Miller C and Miller 

D X 

Pasteurized 

liquid eggs

Egg Establishment 

E and Egg 

Establishment F

X 
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 99

Food Allergens in Ingredient Formulation or in Allergen Advisory Statements: Caramel 

chip cookies

Raw 

Material 

Name Supplier

Egg

Milk

Soy

Wheat

Tree Nut (market 

name)

Peanut

Fish (market name)

Shellfish (market 

name)

Sesame

Food Allergens in

Allergen Advisory

Statements

Vegan 

caramel 

chips

Carmel chip 

Processor A X*

Vegan 

caramel 

chips

Caramel chip 

Processor B X**

Flour Miller C and Miller 

D X

Pasteurized 

liquid eggs

Egg 

Establishment E 

and Egg 

Establishment F

X

* Low potential for unintended milk presence at Caramel Chip Processor A, because Caramel Chip 

Processor A uses different processing lines for the production of vegan caramel chips and non-vegan 

caramel (and other) chips that contain milk.

** Moderate potential for unintended milk presence at Caramel Chip Processor B, because Caramel Chip 

Processor B uses the same processing line for the production of vegan caramel chips and non-vegan 

caramel (and other) chips that contain milk. However, Caramel Chip Processor B routinely verifies its 

allergen cleaning procedures by testing food-contact surfaces of the chip depositor for the presence of 

milk allergen, with repeat cleaning if necessary.
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 100

Food Allergens in Ingredient Formulation or in Allergen Advisory Statements: Peanut 

butter cookies

Raw 

Material 

Name Supplier

Egg

Milk

Soy

Wheat

Tree Nut (market 

name)

Peanut

Fish (market name)

Shellfish (market 

name)

Sesame

Food Allergens in

Allergen Advisory

Statements

Peanut 

butter

Peanut Processor A 

and Peanut 

Processor B

X

Flour Miller C and Miller D

X

Pasteurized 

liquid eggs

Egg Establishment 

E and Egg 

Establishment F

X
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 101

FORM 2-F (Modified) FOOD ALLERGEN LABEL VERIFICATION LIST

PAGE _________

PRODUCTS: Oatmeal cookies, caramel chip cookies, and peanut butter cookies

PLANT NAME: _Bakery B ____ADDRESS: _____________________________________

ISSUE DATE: (mm/dd/yy)____________SUPERSEDES: (mm/dd/yy)__________________

Product Allergen Statement

Oatmeal cookies Contains: Wheat and egg

Caramel chip cookies Contains: Wheat and egg

Peanut butter cookies Contains: Wheat, egg, and peanuts
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 102

FORM 2-G (Modified) PRODUCTION LINE FOOD ALLERGEN ASSESSMENT

PAGE _________

PRODUCTS: Oatmeal cookies, caramel chip cookies, and peanut butter cookies

PLANT NAME: _Bakery B ____ADDRESS: _____________________________________

ISSUE DATE: (mm/dd/yy)____________SUPERSEDES: (mm/dd/yy)__________________

Production Line Assessment

Product Name

Production 

Line 

Egg

Milk

Soy

Wheat

Tree Nut

(almonds)

Peanut

Fish (market 

name)

Shellfish (market 

name)

Sesame

Oatmeal cookies Line A X X

Caramel chip cookies Line A X X

Peanut butter cookies Line B X X X
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 103 

FORM 2-H (Modified) FOOD ALLERGEN CONTROLS

PAGE _________

PRODUCTS: Cookies______ ________________________________________________

PLANT NAME: _Bakery B______ADDRESS: _____________________________________

ISSUE DATE: (mm/dd/yy)________________SUPERSEDES: (mm/dd/yy)________________

ALLERGEN CONTROL STEP: _ Allergen cross-contact: correct color of utensils and tools____

HAZARD(S): __Food allergens (wheat, egg, peanuts)________________________________

Criterion What to 

Monitor How to Monitor

Frequency 

of 

Monitoring

Who 

Monitors Corrective Action/ Correction Verification Records

Correct Color of - Visual During each Production Remove incorrect utensil/tool for On a weekly basis, the - Allergen cross-contact 

color of the utensils observation shift Supervisor cleaning, and then return them to the PCQI reviews the Checklist control procedures for the 

utensils and 

tools

and tools for each 

cookie 

correct area. Determine, if possible, how 

the problem arose and re-train personnel 

for Allergen Cross-Contact 

Controls records (including 

color of utensils and tools, 

including monitoring 

processing as appropriate. corrective actions when procedures

area - Correction (not documented): If the 

problem is before production, this is 

correction.

- Corrective action (documented): If the 

applicable) and documents 

that verification review by 

initialing and dating the 

record. 

- Checklist for Allergen 

Cross-Contact Controls, 

initialed and dated by the 

PCQI, documenting:

problem is during production, this is - Results of 

corrective action, with documentation of monitoring, 

the following on the non-conformance including nonrecord: conformance; and

- Determination of whether dough - When applicable, 

and/or cookies are affected; associated 

- Evaluation of affected dough and/or corrective actions.

cookies for safety; 

- Prevention of affected cookies from 

entering commerce (re-processing 

or diverting the affected dough 

and/or cookies); and

- Recall of cookies if necessary 
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 104 

FORM 2-H (Modified) FOOD ALLERGEN CONTROLS

PAGE _________

PRODUCTS: Cookies______ ________________________________________________

PLANT NAME: _Bakery B______ADDRESS: _____________________________________

ISSUE DATE: (mm/dd/yy)________________SUPERSEDES: (mm/dd/yy)________________

ALLERGEN CONTROL STEP: _ Allergen cross-contact: correct color of apparel and movement of personnel_

HAZARD(S): __Food allergens (wheat, egg, peanuts)________________________________

Criterion

What to 

Monitor How to Monitor

Frequency 

of 

Monitoring

Who 

Monitors Corrective Action/ Correction Verification Records

Correct Color of - Visual During each Production Determine whether incorrect color On a weekly basis, the - Allergen cross-contact 

color of the apparel observation shift Supervisor apparel was due to putting on the wrong PCQI reviews the Checklist control procedures for the 

apparel and 

movement 

for each 

cookie 

item(s) (and, if so, why) or due to a 

violation of the plant traffic pattern 

for Allergen Cross-Contact 

Controls records (including 

color of apparel and 

movement of personnel, 

of processing procedures such that personnel from the corrective actions when including monitoring 

personnel area peanut butter cookie area entered the applicable) and documents procedures

oatmeal/caramel chip cookie production 

area. Re-train personnel as appropriate 

- Correction (not documented): If the 

that verification review by 

initialing and dating the 

record. 

- Checklist for Allergen 

Cross-Contact Controls, 

initialed and dated by the 

employee put on the wrong colored item, PCQI, documenting:

the employee leaves the area and applies

the correct apparel. - Results of 

monitoring, 

- Corrective action (documented): If the including any nonproblem was due to personnel from the conformance; and

peanut butter cookie production area 

entering the oatmeal/caramel chip cookie 

production area, with documentation of 

the following on the non-conformance 

- When applicable, 

associated 

corrective actions

record:

- Determination of whether dough 

and/or cookies are affected;

- Evaluation of affected dough and/or 

cookies for safety; 

- Prevention of affected cookies from 

entering commerce (re-processing 

or diverting the affected dough 

and/or cookies); and

- Recall of cookies if necessary.
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 105 

FORM 2-H (Modified) FOOD ALLERGEN CONTROLS

PAGE _________

PRODUCTS: Cookies______ ________________________________________________

PLANT NAME: _Bakery B__________ADDRESS: ________________________________

ISSUE DATE: (mm/dd/yy)________________SUPERSEDES: (mm/dd/yy)______________

ALLERGEN CONTROL STEP: _Label content: Correct food allergen label specification _________

HAZARD(S): __Food allergens (wheat, egg, peanuts)__________________________

Criterion

What to 

Monitor

How to 

Monitor

Frequency 

of 

Monitoring

Who 

Monitors Corrective Action/ Correction Verification Records

Correct food N/A – N/A N/A N/A - Correction (not documented): If the - Before sending the file to the - Label Content Procedures

allergen label 

specification 

for the 

product 

name and 

the 

“Contains” 

statement on 

product 

labels

Bakery B 

classifies 

its activity 

as 

verification

label content does not match the 

approved food allergen label 

specification before the file is sent to 

the production printer, the Label 

Team Supervisor corrects the label 

content in the file.

- Corrective action (documented): If 

the problem is discovered only after 

packaged cookies have been labeled: 

- Segregate affected product;

- Rework cookies by manually 

transferring the trays of 

incorrectly labeled cookies to 

pouches with the correct label; 

- Investigate root cause and 

modify procedures or re-train 

personnel as applicable; and 

production printer, the Label 

Team Supervisor checks that the 

product name and “Contains” 

statement on the production label 

matches the approved food 

allergen label specification.

- The Production Supervisor prints 

a production label from the 

production printer, pastes that 

printed label onto the production 

sheet, and signs and dates the 

production sheet next to the 

printed label. 

- On a weekly basis, the PCQI 

reviews, initials, and dates the 

records documenting the 

verification review of the 

production labels.

- The approved food 

allergen label specification, 

signed and dated by the 

Label Team Supervisor

- The following records, 

initialed and dated by the 

PCQI: 

- The production sheet 

containing the label 

from the production 

printer, signed and 

dated by the 

Production 

Supervisor; and. 

- Any corrective action 

records.

- Recall any product if necessary. - Within a week of a problem that 

requires corrective action, the 

PCQI reviews, initials, and dates 

the corrective action records
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 106 

FORM 2-H (Modified) FOOD ALLERGEN CONTROLS

PAGE _________

PRODUCTS: Cookies______ ________________________________________________

PLANT NAME: _Bakery B_________ADDRESS: __________________________________

ISSUE DATE: (mm/dd/yy)_________________SUPERSEDES: (mm/dd/yy)_______________

ALLERGEN CONTROL STEP: _Label management_________________________________

HAZARD(S): __Food allergens (wheat, egg, peanuts)________________________________

Criterion

What to 

Monitor

How to 

Monitor

Frequency of 

Monitoring

Who 

Monitors Corrective Action/ Correction Verification Records

Selection of 

the correct 

electronic file 

for the label

N/A –

Bakery B 

classifies its 

activity as 

verification

N/A N/A N/A - Correction (not documented): If the 

Production Supervisor determines that 

a file for the wrong label was sent to 

the production printer but the label has 

not been applied to product, the 

Production Supervisor follows up with 

the Label Team Supervisor to obtain 

the correct file. 

- Corrective action (documented): If the 

problem is discovered only after 

packaged cookies have been labeled: 

- Segregate affected product;

- Rework cookies by manually 

transferring the trays of 

incorrectly labeled cookies to 

pouches with the correct label; 

- Investigate root cause and modify 

procedures or re-train personnel 

as applicable; and 

- Recall any product if necessary.

- The Production Supervisor 

prints a production label from 

the production printer, pastes 

that printed label onto the 

production sheet, and signs 

and dates the production 

sheet next to the printed label

- On a weekly basis, the PCQI 

reviews, initials, and dates the 

records documenting the 

verification review of the 

production labels.

- Within a week of a problem 

that requires corrective action, 

the PCQI reviews, initials, and 

dates the corrective action 

records

- Label Management 

Procedures

- The following 

records, initialed and 

dated by the PCQI:

- The production 

sheet containing 

the label from 

the production 

printer, signed 

and dated by the 

Production 

Supervisor; and

- Any corrective 

actions
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 107

Criterion

What to 

Monitor

How to 

Monitor

Frequency of 

Monitoring

Who 

Monitors Corrective Action/ Correction Verification Records

Application of 

the correct 

label

N/A –

Bakery B 

classifies its 

activity as 

verification

N/A N/A N/A Corrective action (documented): 

- Segregate incorrectly packaged 

products; 

- Rework cookies by manually 

transferring the trays of incorrectly 

labeled cookies to pouches with the 

correct label; 

- Investigate root cause and modify 

procedures or re-train personnel as 

applicable; and 

- Recall any product if necessary

- The line operator:

- Visually checks that the 

correct label is applied; 

and 

- Records, initials, and 

dates the results of the 

visual check on the 

production sheet

- On a weekly basis, the PCQI 

reviews, initials, and dates the 

production sheets with the 

results of the visual check for 

the correct application of the 

product label.

- Within a week of any 

corrective actions, the PCQI 

review, initials, and dates the 

corrective action records.

- Label Management 

Procedures

- The following 

records, initialed and 

dated by the PCQI:

- The production 

sheets 

documenting the 

results of the 

visual check for 

the application 

of the correct 

label; and

- Any corrective 

actions
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 108

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