FDA requires producers of shelf-stable, hermetically sealed low acid or acidified food to obtain FCE and SID registration along with facility registration.
Form FDA 2541 must be filled when first engaging in the manufacture, processing, or packing of acidified foods and/or low-acid canned Foods.
Low acid or acidified food also must comply with Title 21, Code of Federal Regulations Part 113, and 114, Thermally processed low-acid foods packaged in hermetically sealed containers and Acidified foods respectively
Acidified Food Low Acid Food Definition
Acidified Food: Final pH of 4.6 or below AND water activity of 0.85 or above
Low Acid Food: Final pH of above 4.6 AND water activity of 0.85 or above
Form FDA 2541: Food Canning Registration
Form FDA 2541d: Food Process Filing for Low-Acid Retorted Method
Form FDA 2541e: Food Process Filing for Acidified Method
Form FDA 2541f: Food Process Filing for Water Activity/Formulation Control Method\
Form FDA 2541g: Food Process Filing for Low-Acid Aseptic Systems