How do you formulate an anti-dandruff positioning shampoo without making drug claims in the EU?

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.

• In the EU, anti-dandruff shampoos must be positioned as cosmetics, not drugs, by focusing on cosmetic claims like ‘helps reduce visible flakes’ and using approved ingredients such as piroctone olamine or climbazole, while avoiding banned substances like zinc pyrithione in certain concentrations.
• Key details include MOQ guidance of 10,000 units minimum, which can drop to 5,000 for stock packaging, and a sampling timeline of 3-4 weeks after formula approval, including stability checks for viscosity and pH under varied temperatures.
• For testing and docs, we conduct microbial hold-time tests, provide a Product Information File (PIF) with safety assessments, and ensure packaging labels meet EU regulation (EC) No 1223/2009 with ingredient lists in local languages.
• Lead time from production to shipping is 8-12 weeks, factoring in batch QA for leakage risks and pigment dispersion in final mixes.
• We avoid guaranteeing regulatory approval but assist with all necessary compliance steps to streamline your launch.