Quick Answer (for busy buyers)
Here’s the buyer-first summary. If your brand name is on the label, you usually act as the responsible person and must ensure the listing is submitted and kept current.
- For baby care (lotions, washes), we typically see buyers mandate TAMC < 100 CFU/g or ml and TYMC < 10 CFU/g or ml, with strict absence of specified pathogens like Pseudomonas aeruginosa and Staphylococcus aureus.
- For adult skincare, limits are often relaxed to TAMC < 1000 CFU/g and TYMC < 100 CFU/g.
- These specs directly impact formulation and preservative system costs.
- We require your target market (US/FDA, EU/ISO 17516) to set the correct testing protocol.
- In production, we run microbial testing on raw materials, during bulk hold, and on finished goods.
- A key factory reality is managing water activity (Aw) in anhydrous baby products like powder to prevent microbial growth during shelf life.
- We support with full documentation, including Certificates of Analysis (CoA) and challenge test reports for your regulatory submissions.
- Lead time for stability and challenge testing adds 4-8 weeks to development.
Buyer outcome
A launch-ready compliance plan: inputs collected, roles assigned, and update cadence defined.
Most common blocker
Missing facility information + inconsistent ingredient/label snapshots across SKUs.
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This page is a practical buyer guide. For definitive requirements and updates, use FDA resources and qualified regulatory counsel.