Pasta sauces—a kitchen staple made from tomatoes, herbs, and other flavorful ingredients—are regulated by the U.S. Food and Drug Administration (FDA) to ensure they are safe from contamination and spoilage.
Facilities that manufacture, process, pack, or hold pasta sauces intended for consumption in the United States must complete Food Facility Registration with the FDA.
For low-acid or acidified pasta sauces, facilities are also required to obtain Food Canning Establishment (FCE) Registration and submit a Scheduled Process (SID) filing, in addition to standard Food Facility Registration.
The FDA defines Low-Acid Canned Foods (LACF) as any food (excluding alcoholic beverages) with a finished equilibrium pH greater than 4.6 and water activity greater than 0.85, when thermally processed in hermetically sealed containers.
Acidified foods are low-acid foods to which acid(s) or acid food(s) are added to achieve a finished equilibrium pH of 4.6 or below and water activity greater than 0.85.
A Scheduled Process specifies the exact time and temperature combinations, pH levels, container specifications, and other critical factors—such as heat penetration data—required to achieve commercial sterility. Each process must be developed and validated by a qualified Processing Authority for every product variation.
In addition, pasta sauce labels must comply with the FDA’s general food labeling requirements under 21 CFR Part 101. Labels must:
- List all ingredients in correct order
- Declare any major allergens
- Include a Nutrition Facts panel
- Avoid false or misleading claims that could result in misbranding
Liberty Management Group Ltd can help file Food Facility Registration, FCE and SID for your low acid canned and acidified food products and also help with label compliance.
Namrata
Regulatory Consultant
support@libertymanagement.us