Low Acid Canned Foods – FDA Support

Types of FCE-SID Process Filing forms

A low-acid canned food has the following characteristics:

      1. Equilibrium pH value greater than 4.6 and water activity greater than 0.85.
      2. Sealed in a hermetic (air-tight) container (i.e., secure against the entry of microorganisms).
      3. Receives a heat treatment for the purpose of achieving commercial sterility.
      4. Normally stored and distributed under non-refrigerated conditions.

Acidified food

An acidified food is a low-acid food to which acid(s) or acid food(s) are added for the purpose of reducing the pH to a finished equilibrium pH of 4.6 or below. It has a water activity greater than 0.85 and is stored and distributed under nonrefrigerated conditions.

FDA requires manufacturers and processors of low acid canned and acidified food products to submit Food Canning establishment registration using Form 2541 and to submit process filing using Form 2541d, e, f and g.

Form 2541d – Commercial processors who manufacture, process, or pack thermally processed low-acid foods packaged in hermetically sealed containers. Form FDA 2541d is intended for:

Low-acid food products where the growth of microorganisms is controlled through the application of heat to foods.

Form 2541e – Commercial processors who manufacture, process, or pack thermally processed acidified foods packaged in hermetically sealed containers

Form 2541f – Commercial processors who manufacture, process, or pack thermally processed low-acid foods packaged in hermetically sealed containers. Form FDA 2541f is intended for

Low-acid food products where the growth of microorganisms is controlled through the amount of water available for microbiological growth (i.e. “water control” products); and
Low-acid food products where the growth of microorganisms is controlled through multiple physical and/or physicochemical hurdles (i.e. “formulation control” products).

Form 2541g – Commercial processors who manufacture, process, or pack thermally processed low-acid foods packaged in hermetically sealed containers. Form FDA 2541g is intended for:

Low-acid foods where the growth of microorganisms is controlled through the application of heat to foods and where the processing involves use of aseptic processing and packaging

Liberty management Group Ltd. can help companies to file FCE and SID process filings with FDA.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Low Acid Canned Foods & Acidified Foods

The US FDA regulates both Low Acid Canned Foods (LACF) and Acidified Foods (AF).

Low-Acid Canned Foods (LACF):

LACF are low in acid content which provides a conducive environment for the harmful bacteria to grow. FDA regulated LACF products under regulation 21 cfr Part 113.

Manufacturers & processors of LACF are required to register their facility with FDA as a Food Canning Establishment & submit the scheduled process filing for each LACF product. Scheduled process filing provides details of steps in production, time taken, temperatures and other parameters that are necessary to ensure the product’s safety.

Acidified Foods (AF):

Low Acid foods to which acids or acid foods are added to bring the pH level to 4.6 or less are called Acidified foods. Acidified foods are regulated by FDA under 21 cfr Part 114.

Like LACF, AF processors must also register their facility with FDA as Food Canning Establishment & file scheduled process filing for each AF product.

Scheduled process filing for acidified foods include details on the type and amount of acid added, processing times and temperatures.

FDA conducts regular inspections of LACF and AF facilities to ensure regulations are complied with.

Liberty Management Group Ltd. can help you with compliance with FDA requirements for LACF & AF products.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Low Acid Canned Food and Acidified Food

Low-acid canned foods are foods 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. They are processed at high
temperatures in airtight containers to prevent contamination & growth of
harmful bacteria.

An acidified food is a low-acid food to which acid ingredients are added and which
has a finished equilibrium pH of 4.6 or below and a water activity greater than
0.85. This makes the food more acidic and creates an environment that is
unfavorable for the growth of microorganisms.

Low-acid canned foods & Acidified foods are regulated by the US FDA and
manufacturers and processors must follow strict guidelines for processing and labeling these
products.

Manufacturers and processors of Low-acid canned foods & Acidified foods must register with FDA
as a food facility, submit a Food Canning Establishment Registration &
process filing of such products.

FDA FCE (food canning establishment registration) is a process by which facilities
that engage in the commercial processing and packing of acidified and low-acid
canned foods must register with the US FDA.

Liberty Management Group Ltd. can help you with Food Facility Registration, FCE, label compliance and other FDA regulations.

Namrata

Regulatory Consultant

support@libertymanagement.us

www.fdahelp.us

FDA LACF Registration

All food facilities engaged in manufacturing, packing, labeling or holding of food for consumption in US must be FDA registered. In addition all foreign facilities must designate a US Agent for the purpose of FDA communications.

In addition, all commercial processors of low-acid and acidified foods located in the US and all foreign processors who export low-acid canned food (LACF) or acidified food products into the US must also register their processing plants (Food Canning Establishment Registration – FCE) and submit scheduled process filing with FDA.

LACF is any food 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 is a low-acid food to which acids are added and which has a finished equilibrium pH of 4.6 or below and a water activity greater than 0.85.

Any LACF food offered for import that is manufactured in a facility with no FCE registration will be refused admission into US. Wholesalers, distributors, broker and importers are not required to register or file processes. But they must ensure that their suppliers FCE registration is in order.

Any manufacturer that is required to register as an FCE must also submit its scheduled process for all of its Low Acid Canned foods to FDA to obtain a SID number for all such products. The manufacturer’s scheduled process must be reviewed and accepted by FDA before any such food is permitted to enter the US. The manufacturer must update the SID filing if there is any change in the manufacturing process, container type, size etc.

Liberty Management Group LTD is one of the leading FDA consulting group in the USA. LMG provides assistance with Food Facility Registration, Food Canning Establishment Registration, Scheduled process filing and Label Review.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: January 9, 2019