Food

Acidified & Low-Acid Canned Foods (LACF)

On this page:

Introduction
Guidance for Industry on Acidified Foods
Establishment Registration & Process Filing

Introduction

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 on Acidified Foods

Draft Guidance for Industry: Acidified Foods September 2010

This guidance is intended for processors of acidified foods, fermented foods, and acid foods. It pertains to the current good manufacturing practice (CGMP) requirements in 21 CFR part 114 for acidified foods and to the “Specific Requirements and Conditions for Exemption From or Compliance With an Emergency Permit” for acidified foods in 21 CFR 108.25 and is intended to assist commercial food processors in determining whether their food products are subject to these regulations.

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.