Regulatory information
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 guarantees the product's regulatory compliance. This page identifies the Responsible Person for Ambernay products and outlines the frameworks we comply with in each market.
Role of the EU Responsible Person
The EU Responsible Person is the legal point of contact for all regulatory matters concerning Ambernay products placed on the EU market, including:
Maintenance of, and authority access to, the Product Information File (PIF)
Product notifications via the Cosmetic Products Notification Portal (CPNP)
Serious Undesirable Effect (SUE) reporting under Article 23
Responses to requests from market surveillance authorities
Ingredient compliance under Annexes II–VI of Regulation (EC) No 1223/2009
Regulatory Compliance Framework
Ambernay products are developed, tested and placed on the market in accordance with the following frameworks.
European Union
Regulation (EC) No 1223/2009 on cosmetic products
Common Criteria for claim substantiation — Regulation (EU) No 655/2013
ISO 24444 (SPF), ISO 24443 (UVA), ISO 11930 (preservation efficacy)
CPNP notification completed before market entry
United States
FD&C Act cosmetic provisions, as amended by MoCRA (2022)
FDA OTC monograph system for sunscreen (SPF) products
FTC guidance on substantiation of cosmetic claims
Safety Assessment
Every Ambernay product has a completed cosmetic product safety report on file, prepared by a qualified safety assessor as required under Article 10 of Regulation (EC) No 1223/2009. The safety assessment forms part of the Product Information File maintained by the EU Responsible Person.
Serious Undesirable Effects
If you experience a serious adverse reaction to an Ambernay product, contact us immediately at eu@ambernay.com. Reports are handled in accordance with Article 23 of Regulation (EC) No 1223/2009 and forwarded 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.
Last updated · August 2026