Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

        Guidance Documents & Regulatory Information by Topic (Food and Dietary Supplements)

Acidified & Low-Acid Canned Foods Guidance Documents & Regulatory Information Home
          Food
          Guidance & Regulation (Food and Dietary Supplements)
          Guidance Documents & Regulatory Information by Topic (Food and Dietary Supplements)
          Acidified & Low-Acid Canned Foods Guidance Documents & Regulatory InformationGuidance Documents & Regulatory Information by Topic (Food and Dietary Supplements) Acidified & Low-Acid Canned Foods Guidance Documents & Regulatory Information
  	
        Share
    Post
    Linkedin

    Email
    PrintDue to increased telework to mitigate COVID19, there will be an increased delay in processing paper submissions. It is recommended that whenever possible you submit registrations and process filings **electronically**. If you need additional assistance please send an e-mail to LACF@FDA.HHS.GOV with your issue stated in the subject line.


Federal Regulations require commercial processors of shelf stable acidified foods and low-acid canned foods in a hermetically sealed container to be sold in the United States to register each establishment and file scheduled processes with the Food and Drug Administration for each product, product style, container size and type and processing method (21 CFR 108). This website contains instructions for establishment registration and process filing along with other information useful to manufacturers of these types of products.

A low-acid canned food (LACF) is any food (other than alcoholic beverages) with a finished equilibrium pH greater than 4.6 and a water activity greater than 0.85, excluding tomatoes and tomato products having a finished equilibrium pH less than 4.7.

An acidified food (AF) is a low-acid food to which acid(s) or acid food(s) are added and which has a finished equilibrium pH of 4.6 or below and a water activity (aw) greater than 0.85.

Guidance for Industry

*Guidance documents contain nonbinding recommendations*

Guidance for Industry: Low-Acid Foods Packaged in Hermetically Sealed Containers (LACF) Regulation and the FDA Food Safety Modernization Act (December 2021)
	Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format (November 2016)
	Guidance for Industry: Dear Manufacturer Letter Regarding Changes to FDA’s Administration of Process Filings (Forms FDA 2541a and FDA 2541c) for Acidified Foods and Low-Acid Canned Foods (January 2014)Establishment Registration & Process Filing

All commercial processors of low-acid and acidified foods located in the United States and all processors in other countries who export low-acid canned food or acidified food products into the United States must register their processing plants with FDA. Wholesalers, importers, distributors, brokers, etc. are not required to register and file processes. However, they must ensure that processing firms they represent comply with all registration and process filing requirements.

Resources and Information for Establishment Registration & Process Filing

	Paper Submissions
		Electronic Submissions

                                                                                  Content current as of:
      12/21/2021
                  
                   
Regulated Product(s)
		 Food & BeveragesAcidified & Low-Acid Canned Foods Guidance Documents & Regulatory Information
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop