Think of CTEs as moments where something changes hands or changes form. Ingredients arrive at your dock — receiving CTE. Flour, water, yeast, and salt become bread — transformation CTE. Loaves get loaded and delivered — shipping CTE.

The transformation CTE is where most food manufacturers need the most attention. A bakery running a poolish through overnight ferment and then into final dough has two transformation events. A confectionery manufacturer tempering chocolate, enrobing centres, and packaging has multiple steps.

The question of granularity: does every mixing step count? The FDA’s guidance says a CTE occurs when a food is “transformed” — becomes a different product or is combined with other ingredients. Packaging finished goods into cases doesn’t usually create a new CTE, but mixing two batches of different lot codes does.

Getting your CTEs identified correctly is the first step to FSMA 204 compliance.