Definition
The regulation replaced Directive 76/768/EEC and introduced a single EU-wide framework. Core obligations include: a Product Information File (PIF) kept available to authorities for 10 years post-sale; mandatory notification via the CPNP portal before market launch; a safety assessment (Cosmetic Product Safety Report) signed by a qualified toxicologist; a Responsible Person established in the EU for non-EU brands; and complete INCI ingredient labeling with declared allergens above threshold concentrations (European Commission, accessed 2026-05-27).
The regulation lists 26 obligatory declared allergens at concentrations above 0.001% in leave-on products (including linalool, limonene, citronellol, geraniol, and 22 others), with an extension to approximately 80 substances under final adoption in 2026. All animal testing on cosmetic ingredients has been banned in the EU since March 2013 (ECHA, accessed 2026-05-27).
Impact on niche perfumery
For small independent niche houses, the regulation imposes significant compliance costs: external toxicologist fees (typically €500–2,000 per formula), CPNP subscription, and ongoing regulatory monitoring. Three practical consequences:
- Many small artisanal perfumers use contract regulatory consultants rather than in-house expertise.
- Formulas with high natural concentrations (absolutes of oakmoss, bergamot, rose) require careful allergen calculation before release.
- Non-EU brands exporting to the EU must appoint a European Responsible Person, adding a structural cost layer.