Question

As per the latest FSSAI microbiological specifications, what is the number of samples of infant formula to be tested to clear a batch with respect to Cronobacter spp.?

• A. 05
• B. 25
• C. 30
• D. 60

Hint:

Sampling Plans for Infant Formula:
Cronobacter spp. $\rightarrow \mathbf{n = 30}$, $c = 0$ (Absent in 10 g).
Salmonella spp. $\rightarrow \mathbf{n = 60}$, $c = 0$ (Absent in 25 g).

Answer 1

The Correct Option is C

Step 1: Understanding the Concept:
Two-class sampling plan for zero-tolerance neonatal pathogens: FSSAI and Codex Alimentarius mandate an intensive sampling plan of $n = 30$ ($c = 0$, $m = 0/10 ext{ g}$) for Cronobacter sakazakii in powdered infant formula.
Key Formula or Approach:
\[ \text{FSSAI 2-Class Sampling Plan for } \textit{Cronobacter}\text{: } n = \mathbf{30 \text{ Sample Units}}, \; c = 0, \; m = \text{Absent in 10 g} \]

Step 2: Detailed Explanation:
In dairy regulatory food safety and infant formula microbiological criteria (FSSAI Compendium of Food Safety Standards Codex CAC/RCP 66-2008):
- {Cronobacter species (formerly Enterobacter sakazakii): A severe opportunistic pathogen associated with fatal neonatal necrotizing enterocolitis, sepsis, and meningitis in infants fed powdered infant formula.
- Under the FSSAI two-class statistical sampling plan for clearing commercial manufacturing batches:
1. Number of Sample Units ($n$): Exactly 30 sample units (n = 30) (C) must be drawn and tested from each production batch.
2. Acceptance Number ($c$): $c = 0$ (Zero tolerance).
3. Microbiological Criterion ($m$): Completely Absent in $10\text{ g}$ per sample unit ($m = 0/10\text{ g}$).

Step 3: Final Answer:
Therefore, the number of samples to be tested is 30, matching option (C).