Tag: FCE

Types of FCE-SID Process Filing forms

Low-acid canned food

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).

  1. 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.

  1. 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