Regulatory Oversight Guide

Overview of Food Processing Regulations for Different Types of Products

Food processors must follow labeling and other regulationsin addition to those listed below. Each producer is responsible for contacting the relevant regulatory authoritybefore production begins. Each producer will be treated as a separate entity and inspected by the relevant authorities.

 

Type of Product

Regulations that Apply

Inspected By

OTHER

Acid foods(naturally fermented vegetables, sauerkraut; most fruits, some tomatoes

21 CFR 110 Good Manufacturing Practices (GMP)

Food & Drug Protection Division of NCDA & CS

pH < 4.6

FDA Bioterrorism Registration Required

Acidified Foods

(Tomato sauces, pickled beans, chutneys, some moles—all hot filled)

21 CFR 114 Acidified Foods

GMP

Food & Drug Protection Division of NCDA & CS

Scheduled Process Required; Registration with FDA required as acidified food producer.

Cold-filled products(dressings and condiments)

21 CFR 114 Acidified Foods

GMP

Food & Drug Protection Division of NCDA & CS

Usually are acid products with a pH < 4.6. FDA Bioterrorism Registration Required

Dried products

(tomatoes, mushrooms, apples .Also dried mixes, trail mixes)

GMP

Food & Drug Protection Division of NCDA & CS

FDA Bioterrorism Registration Required

Standard Fruit Preserves

GMP

Food & Drug Protection Division of NCDA & CS

FDA Bioterrorism Registration Required

Baked goods

(Breads, most cakes, fruit pies, etc…)

GMP

Food & Drug Protection Division of NCDA & CS

FDA Bioterrorism Registration Required

Specialty Preserves

Low-sugar fruit preserves,

vegetable preserves (may be acidified)

GMP

Food & Drug Protection Division of NCDA & CS

If acidified, see above.

FDA Bioterrorism Registration Required

Food vendor carts

NC Foodservice Rules

Orange County Department of Environmental Health

Caterers

NC Foodservice Rules

Orange County Department of Environmental Health

Foods prepared & sold refrigerated or frozen

salsa, pesto, applesauce

GMP

Food & Drug Protection Division of NCDA & CS

FDA Bioterrorism Registration Required

Pasteurized juices & ciders

HACCP

Food & Drug Protection Division of NCDA & CS

FDA Bioterrorism Registration Required

Certain prepared seafood products

GMP

21 CFR 123 – Seafood HACCP Rules-Fish and Fishery Products

Food & Drug Protection Division of NCDA & CS

FDA Bioterrorism Registration Required

 

Oversight Guidance:

Food & Drug Protection Division of NCDA & CS – Phone: 919-733-7366

Orange County Department of Environmental Health – Phone: 919-245-2360