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, hair care products face strict ingredient restrictions.
- Key restricted substances include preservatives like methylisothiazolinone (MIT) in rinse-off products, hair dye ingredients such as p-phenylenediamine (PPD) with concentration limits, and 26 fragrance allergens requiring labeling above thresholds.
- For OEM production, we need full ingredient lists from clients to screen against Annexes II-VI during formulation.
- From a factory perspective, compliance testing is integrated into our workflow.
- We conduct stability, microbial, and specific toxicological tests for restricted ingredients, alongside documentation like the Cosmetic Product Safety Report (CPSR) and Product Information File (PIF).
- However, final regulatory approval depends on the EU Responsible Person; we only support with testing and doc preparation.
- Operationally, MOQ for compliant hair care often starts at 3,000 units per SKU to cover testing costs.
- Sampling timelines extend by 2-4 weeks for pre-compliance batch checks, including ingredient level verification.
- Packaging requires EU-label reviews for ingredient lists in English, and we align claims with test data.
- Lead time adds 1-2 weeks for doc finalization and potential reformulation if limits are exceeded.
- We assist by providing test reports and label reviews, but cannot guarantee approval.
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.
⚠️
This page is a practical buyer guide. For definitive requirements and updates, use FDA resources and qualified regulatory counsel.