United States: Food Safety And Inspection Service Issues New Allergen Handling Guidelines

Last Updated: November 27 2015
Article by William W. Wales, Robert R. Stead and Alexandra Robinson French

On Nov. 13, the Food Safety and Inspection Service (FSIS) released new guidelines regarding management of ingredients that could trigger adverse reactions in consumers with sensitivities to certain food ingredients. The guidelines are said to represent "FSIS's current thinking," and producers, including FSIS-regulated establishments, state-regulated establishments, and operations where all or part of the premises meet the "food processing plant" definition of the 2013 Food Code, are encouraged to adhere to the new guidelines. The guidelines provide information on processing, handling and storing products with allergenic ingredients. The focus of the guidelines is on meat and poultry products.

The FSIS guidelines involve three main principles: (1) identify, (2) prevent and control and (3) declare.

Identify Guidelines

FSIS recommends that producers implement a meticulous, comprehensive hazard analysis to identify and control allergens. This hazard analysis should be part of a Hazard Analysis and Critical Control Point (HACCP) plan. The new guidelines indicate that regulated producers should ensure their hazard analyses include all steps of the production process, from receiving to packaging and shipment. FSIS encourages the following "practical steps" to identify allergens:

  • Review lists of ingredients and products used to determine whether they are or may contain allergens
  • Using a schematic, conduct a walkthrough of the facility, noting paths of allergenic ingredients and products and areas where cross-contact may occur
  • Keep lists of ingredients used in product formulations and records of labels to compare against incoming ingredients
  • Ensure incoming ingredients containing allergenic material are clearly labeled and identified
  • Color code allergen-containing ingredients and products
  • Store ingredients containing allergenic materials in separate, designated areas that are clearly identified and marked
  • Become familiar with letters of guarantee from suppliers
  • Maintain open communication of expectations with suppliers and inquire about their allergen control programs

Alongside the FSIS guidelines for implementing procedures to identify allergens, the FSIS provided guidance on distinguishing between Letters of Guarantee (LOGs) and Certificates of Analysis (COAs), and further clarified that an annual LOG from a supplier will typically be insufficient to support a producer's hazard analysis decisions. FSIS encourages producers to cross-reference labels with both incoming and outgoing products and to follow FSIS's existing labeling guidelines.

Prevent and Control Guidelines

FSIS also issued guidelines for preventing cross-contact of allergenic and non-allergenic products, as well as misbranding of items containing allergenic ingredients. FSIS recommends the following "practical steps" for preventing cross-contact:

  • Color code ingredient packages, supplies, uniforms, and utensils used for products containing allergens throughout processing to facilitate identification 
  • Document cleaning procedures with checklists including spill clean-up procedures
  • Employ a method for verification and validation of cleaning
  • Maintain a documented process flow along with mapping the route of allergenic product through the facility
  • Employ methods for tracking lot codes through production 
  • Carefully evaluate rework and work-in-progress
  • Dedicate equipment or separate allergenic products by time, space, etc. (if dedication of equipment is not feasible).

Cleaning and sanitization of equipment, utensils and food contact surfaces (FCS) should occur after any contact with an allergenic product. FSIS also recommends that producers make plans to handle non-allergenic products before handling allergenic products, to help prevent cross-contact. Further, FSIS recommends avoiding use of the same cooking medium for both allergenic and non-allergenic products.

FSIS states in the guidelines that the agency does not recognize a threshold for any allergenic ingredient—even a trace presence of any of the above-listed allergen imposes a mandatory labeling requirement under the current rules and guidelines. To test for allergens, FSIS encourages producers to use test kits as a supplement to existing cleaning and sanitizing programs.

Declare Guidelines

The final area of FSIS's new guidelines deals with declaring the presence of allergens in packaging, labeling and storage. Once a regulated producer identifies potential allergens, FSIS warns, the producer has a responsibility to ensure the product is properly packaged, labeled and stored. FSIS recommends the following "practical steps" to avoid mislabeling:

  • Systems and checklists for labeling of the final product
  • Conduct simulations with inaccurate product labels to test systems, checklists and procedures
  • Color coding of products containing allergenic ingredients
  • Procedures for labeling discrepancies to ensure product disposition is evaluated
  • Verify accuracy of product labels
  • Methods of tracking lot codes through the production, storage and shipping process
  • Storage of products containing allergenic materials in areas that are clearly identified and marked.

FSIS emphasized the importance of product separation in storage as well as the importance of following a formal HACCP system to carry out producer obligations under the regulations. FSIS also clarified that "may contain" statements are not required for the mere presence of an allergen, but that "processed in a facility that uses" labels are only to be used when good manufacturing practices cannot reasonably eliminate the unintended presence of the allergen in question. Further, FSIS encourages producers to view its document "Compliance Assistance: Allergens-Voluntary Labeling Statements" for more information on labeling statements.

In addition to the three primary focus areas of the guidelines, FSIS encouraged producers to implement allergen handling training for employees. While the guidelines are non-mandatory, FSIS reminds producers that a failure to declare presence of one of the following allergens may result in a Class I or Class II recall:

  • Wheat
  • Crustacean shellfish
  • Eggs
  • Fish
  • Peanuts
  • Milk
  • Tree nuts
  • Soybeans

Producers serving countries outside the U.S. should also adhere to reporting requirements for other allergens under local law. FSIS also notes that compliance with existing federal regulations and labeling laws remains mandatory.

The FSIS Allergen Guidelines and appendices, labeling policies, and the Voluntary Labeling Statements Guidance are available for PDF download.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

In association with
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.