Flourea Beauty

FDA Compliance, CPSR & Product Information File (PIF/DIP) Guidance

Manufacturing and Regulatory Support

Flourea works with a network of trusted manufacturing partners in Canada and the United States. Our partners are expected to operate in accordance with applicable cosmetic manufacturing and regulatory requirements, and some may also hold Good Manufacturing Practice (GMP) certifications. Specific supporting documentation may be available upon request.

Flourea does not provide a single, universal certification covering all products, manufacturers, or markets. Compliance requirements vary by product type and destination market, and documentation should be reviewed on a product-by-product and market-by-market basis.

Important Compliance Information for U.S., EU, and UK Markets

Cosmetic compliance is a shared regulatory responsibility, but the legal obligations differ by market.

In the United States, cosmetic products are regulated by the U.S. Food and Drug Administration (FDA). Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the “responsible person” is generally the manufacturer, packer, or distributor whose name appears on the product label. Depending on the circumstances, legal obligations may include product listing, access to facility registration information, label compliance, recordkeeping, and serious adverse event reporting.

In the European Union, each cosmetic product placed on the market must have a designated Responsible Person (RP). The RP is responsible for ensuring compliance with Regulation (EC) No 1223/2009, including maintaining the Product Information File (PIF), ensuring a Cosmetic Product Safety Report (CPSR) is in place, and completing notification through the Cosmetic Products Notification Portal (CPNP) before the product is placed on the EU market.

In Great Britain, each cosmetic product must also have a designated Responsible Person, and products must be notified through the Submit Cosmetic Product Notifications (SCPN) service. The Responsible Person must keep a PIF in English and ensure the required safety and compliance documentation is maintained.

Flourea’s Role

Flourea does not act as the Responsible Person for the EU or Great Britain unless expressly agreed in writing for a specific arrangement. Flourea also does not assume the legal responsibilities assigned by law to the U.S. responsible person, EU Responsible Person, or GB Responsible Person for your brand’s finished products unless specifically stated otherwise in a separate written agreement.

Instead, Flourea may support brand owners and their designated compliance partners by providing certain product-related documents or manufacturing information that may assist with regulatory review and market access preparation.

Supporting Documentation That May Be Available Upon Request

Depending on the product and manufacturer, Flourea may be able to provide supporting materials such as:

  • ingredient lists
  • product specifications
  • manufacturing information
  • available GMP or quality-related documentation
  • other supporting documents that may assist your compliance review

Availability of documentation may vary by manufacturer, product, and intended market. Certain documents may require additional lead time, may be subject to confidentiality limitations, or may need to be requested for a specific SKU.

What Flourea Does Not Provide Automatically

Unless expressly stated otherwise, Flourea does not automatically provide or guarantee:

  • a single centralized certification covering all products or all markets
  • Responsible Person services for the EU or GB
  • automatic preparation of the Product Information File (PIF)
  • automatic preparation of the Cosmetic Product Safety Report (CPSR)
  • legal advice regarding regulatory classification, claims, labeling, or market-specific compliance

Steps for Brands Seeking Compliance Documentation

To support your regulatory process, we recommend the following:

  1. Identify the market where the product will be sold, such as the U.S., EU, or Great Britain.
  2. Confirm the documentation required for that market.
  3. Appoint your designated Responsible Person or regulatory compliance partner where required.
  4. Contact Flourea to request available supporting documentation for the specific product(s).
  5. Submit those materials to your Responsible Person, safety assessor, or regulatory advisor for review and completion of any required filings or safety documentation.

Responsibility for Final Compliance

The brand owner and/or its designated Responsible Person remain responsible for ensuring that finished cosmetic products, labeling, product claims, notifications, and market placement activities comply with all applicable laws and regulations in the jurisdictions where the products are sold. This includes, where applicable, maintaining the PIF, obtaining a CPSR, completing CPNP or SCPN notifications, and meeting relevant U.S. MoCRA obligations.

For product-specific documentation requests, please contact Flourea directly.