August 2001

This guidance is reference material for investigators and other FDA personnel. The guidance

does not bind FDA and does not confer any rights, privileges, benefits or immunities for or

on any person(s). An alternative approach may be used if such an approach satisfies the

requirements of the applicable statutes, regulations, or both.

FDA has developed inspection guidance identifying the following areas in the manufacture ofg

foods that may result in undeclared food allergens: 1) Products that contain one or more allergenic

ingredients, but the label does not declare the ingredient in the ingredient label; 2) Products that

become contaminated with an allergenic ingredient due to the firm’s failure to exercise adequate

control procedures; 3) Products that are contaminated with an allergenic ingredient due to the

nature of the product or process; 4) Products that contain a flavor ingredient that has an allergenic

component, but the label of the product only declares the flavor; and 5) Products that contain a

processing aid that have an allergenic component, but the label does not declare it.

Comments and suggestions regarding this document should be submitted to the Dockets

Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,

Rockville, MD 20852, Email: fdadockets@oc.fda.gov. Please refer to Docket No. 01D-0316

when commenting on this document.

For technical questions concerning food allergens, please contact: Kathy Gombas, Office of Field

Programs (HFS-615), Center for Food Safety and Applied Nutrition, Food and Drug

Administration, 200 C St. SW., Washington, DC 20204, 202-205-4231, FAX 202-260-0136.

For questions concerning regulatory procedures, please contact: Barbara Marcelletti, Office of

Regional Operations (HFC-130), Office of Regulatory Affairs, Food and Drug Administration,

5600 Fishers Lane, Rockville, MD 20857, 301-443-6919.

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GUIDANCE ON INSPECTIONS OF FIRMS PRODUCING FOOD

PRODUCTS SUSCEPTIBLE TO CONTAMINATION WITH

ALLERGENIC INGREDIENTS

August 2001 (Editorial Changes Only)

This guidance is reference material for investigators and other FDA personnel. The

guidance does not bind FDA and does not confer any rights, privileges, benefits or

immunities for or on any person(s). An alternative approach may be used if such an

approach satisfies the applicable statutes, regulations or both.

INTRODUCTION

Prior to conducting inspections involving any manufacturer using ingredients that are

considered allergens, review the general inspectional instructions in the Investigations

Operations Manual (IOM) Chapter 5 -Establishment Inspections, particularly those in

IOM 530 -Food Inspections; and review Compliance Program 7321.005 -Domestic

NLEA, Nutrient Sample Analysis and General Food Labeling Program and Compliance

Policy Guide Section 555.250, titled “Statement of Policy for Labeling and Preventing

Cross-contact of Common Food Allergens”.

Each year the Food & Drug Administration (FDA) receives reports of consumers who

experienced adverse reactions following exposure to an allergenic substance in foods.

Food allergies are abnormal responses of the immune system, especially the production

of allergen-specific IgE antibodies to naturally occurring proteins in certain foods that

most individuals can eat safely. Frequently such reactions occur because the presence of

the allergenic substance in the food is not declared on the food label. Current regulations

require that all added ingredients be declared on the label, yet there are a number of

issues that have arisen in connection with undeclared allergens that are not clearly

covered by label regulations. This guidance covers the following problem areas:

1. Products that contain one or more allergenic ingredients, but the label does not

declare the ingredient in the ingredient statement;

2. Products that become contaminated with an allergenic ingredient due to the firm's

failure to exercise adequate control procedures, e.g. improper rework practices,

allergen carry-over due to use of common equipment and production sequencing,

inadequate cleaning;

3. Products that are contaminated with an allergenic ingredient due to the nature of

the product or the process; i.e., use of common equipment in chocolate

manufacturing where interim wet cleaning is not practical and only dry cleaning

and product flushing is used;

4. A product containing a flavor ingredient that has an allergenic component, but the

label of the product only declares the flavor, e.g., natural flavor. Under current

regulations, firms are not required to declare the individual components of

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flavors, certain colors, and spices. However, firms are encouraged to specifically

label allergenic components/ingredients that are in spices, flavors, and colors;

5. Products that contain a processing aid that have an allergenic component, but the

label does not declare it. Processing aids that contain allergenic ingredients are

not exempt from ingredient declaration under the incidental additives regulation

(21 CFR 101.100(a)(3)), and therefore, must be declared.

FDA believes there is scientific consensus that the following foods can cause serious

allergic reactions in some individuals and account for more than 90% of all food

allergies: Peanuts, Soybeans, Milk, Eggs, Fish, Crustacea, Tree nuts, Wheat

If you are requested to do a follow-up investigation involving an allergic reaction which

appears to be caused by an undeclared food other than the eight foods listed above, then

contact the CFSAN / Office of Field Programs regulatory contact listed in the compliance

program for guidance.

PRODUCT DEVELOPMENT

Determine whether the firm identifies potential sources of allergens starting in the

product development stage. For example, do they identify for each product all

ingredients, ingredient components, processing aids, rework, processing steps,

environmental conditions, and product carry over due to use of common equipment? Are

potential sources of allergen contamination identified at each step?

Determine whether the products contain allergenic ingredients. For the most frequently

produced products, request formulas. If formula information is refused, construct

formulations by observing production.

Determine if the firm has assessed whether the packaging material used in direct contact

with the product contains an allergen; e.g., foil coated with wheat ingredient as releasing

agent.

Does the firm use processing aids in the manufacture of the food? If so, do the

processing aids contain allergenic ingredients? If so, what are the allergenic ingredients?

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Does the firm use spices, flavors, or colors that contain allergenic components? If so, do

these spices, flavors or colors contain allergenic ingredients? If so, what are the

allergenic ingredients?

RECEIVING

Determine whether the firm uses allergenic ingredients.

Determine how these allergenic ingredients are handled at receiving and how they are

identified and/or segregated in raw material storage.

Determine if the firm stores any of these allergenic ingredients in bulk tanks. If yes, how

are the contents of the bulk tanks identified?

Determine what the firm’s procedure is for receiving ingredients into the bulk tank and

what controls are in place to ensure proper product identity at all times.

Determine if the firm receives any raw materials that are labeled with a statement, such as

"this product was processed on machinery that was used to process products containing

(allergen)" or "may contain (allergen)". If so what ingredients? How are such statements

reflected on the label of the firm’s finished product?

Determine whether a label from each incoming lot of finished product labels is visually

checked, either upon receipt or during production, to ensure the ingredient statement is

correct for the intended product and that it is not a carton of mixed labels.

EQUIPMENT

Try to inspect the equipment before processing begins and document the adequacy of

clean up. For example, is there a build up of residual materials or pockets of residue in

corners that may contain an allergen from previous runs? What is the condition of the

conveyor belts? Is there any product build-up above processing zones? Also observe

whether the firm checks the processing lines for cleanliness prior to production and

whether