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.
- Under EU Regulation (EC) No 1223/2009, fragrance allergens in cosmetics require labeling when above threshold levels.
- For hair care products like shampoos or conditioners (typically rinse-off), the limit is 0.01% for each of the 26 allergens, such as limonene or linalool.
- This must be clearly stated in the ingredient list, often using INCI names, to avoid non-compliance risks for brands selling in the EU market.
- In our OEM/ODM workflow, we integrate allergen management from the start.
- During formulation feasibility, we review ingredient suppliers for allergen concentrations and adjust recipes if needed.
- For sampling, we conduct GC-MS analysis to verify allergen levels, which adds about 2-3 weeks to the timeline and impacts MOQ decisions, as smaller batches may require more frequent testing.
- Packaging design must allocate space for full ingredient declarations, and we ensure labels meet EU formatting standards to prevent rework.
- Lead times factor in compliance checks, with production gates including allergen documentation like the Product Information File (PIF).
- We assist with testing and documentation but cannot guarantee regulatory approval, as final responsibility lies with the brand.
- Cost considerations include testing fees, which vary by SKU complexity, and MOQs (e.g., 10,000 units) help amortize these expenses.
- Always provide your target market details upfront to streamline the process.
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.
