One of the most common misconceptions in food packaging is the term "FDA Approved." The FDA does not formally certify or approve food packaging materials. Instead, manufacturers declare compliance with FDA regulations under Title 21 of the Code of Federal Regulations (21 CFR Parts 170-199) [1]. This distinction is critical for Southeast Asian exporters selling on Alibaba.com — buyers may ask for "FDA certification," but what they actually need is documentation proving your materials meet FDA requirements.
Under the FDA framework, food contact substances (FCS) must undergo premarket notification if they are new substances not already covered by existing regulations. The manufacturer is responsible for ensuring that materials do not chemically react with food, alter taste or odor, or allow harmful migration of substances into food [1][2]. For exporters, this means maintaining detailed documentation including material composition, intended use conditions, and any migration test results.
"FDA is not an official certification. The manufacturer declares compliance. 21 CFR defines permitted substances and migration limits. EU has separate regulations (1935/2004)." [1]
The 21 CFR framework includes Conditions of Use (A through H) defining temperature ranges and contact duration, and Food Types (I through IX) categorizing different food categories (aqueous, fatty, acidic, etc.) [2]. Your packaging must be tested and documented for the specific conditions under which it will be used. For example, a bag designed for dry cookies has different requirements than one intended for hot-fill sauces.
