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
Published on: January 9, 2019