Responsible Person / Compliance
Under EU Cosmetics Regulation (EC No 1223/2009), every cosmetic product placed on the European Union market must have a designated Responsible Person — a legal entity established within the EU that takes responsibility for regulatory compliance.
EU Responsible Person
LuminaLab Sp. z o.o.
Sportowa 2
82-500 Kwidzyn
Poland
Email: eu@ambernay.us
The EU Responsible Person is the legal contact for all regulatory matters concerning Ambernay products placed on the EU market, including:
- Product Information File (PIF) maintenance and access
- CPNP (Cosmetic Products Notification Portal) notifications
- Serious Undesirable Effect (SUE) reporting
- Market surveillance authority requests
- Ingredient compliance under Annexes II, III, IV, V and VI of EC 1223/2009
US Market Contact
LuminaLab LLC
415 Mission St
San Francisco, California 94105
USA
Email: info@ambernay.us
Regulatory compliance framework
Ambernay products are developed and placed on the market in compliance with the following regulatory frameworks:
European Union
- Regulation (EC) No 1223/2009 on cosmetic products
- Common Criteria for cosmetic claim substantiation (EU 655/2013)
- ISO 24444 (SPF testing), ISO 24443 (UVA testing), ISO 11930 (preservation efficacy)
- EU Cosmetic Products Notification Portal (CPNP) notification before market entry
United States
- FD&C Act cosmetic provisions (as amended by the Modernization of Cosmetics Regulation Act 2022 — MoCRA)
- FDA OTC monograph system for SPF products
- FTC guidelines on cosmetic claim substantiation
Safety Assessment
Every Ambernay product has a completed cosmetic safety assessment on file, conducted by a qualified safety assessor as required under Article 10 of EC 1223/2009. The safety assessment is part of the Product Information File maintained by the EU Responsible Person.
Serious Undesirable Effects (SUE)
If you experience a serious adverse reaction to an Ambernay product, please contact us immediately at eu@ambernay.us. SUE reports are processed in accordance with Article 23 of EC 1223/2009 and reported to the relevant competent authority.
Product Information File access
Market surveillance authorities may request access to the Product Information File for any Ambernay product. Requests should be directed to the EU Responsible Person at the address above.
→ Method | → Our Standard | → Contact