Ensuring product compliance is a key responsibility for brand owners, especially when selling products in regulated markets such as the EU/UK. Below is an overview of the roles and responsibilities related to compliance documentation and how Blanka supports these efforts.
Introduction to Product Compliance Responsibility
Product compliance requires adherence to various regulatory standards, often including safety assessments and documentation like the Product Information File (PIF/DIP) and Cosmetic Product Safety Report (CPSR). These documents are critical for ensuring consumer safety and market approval. Under EU/UK regulations, each brand must designate a Responsible Person (RP), who will be in charge of:
Creating and maintaining the Product Information File (PIF/DIP).
Fulfilling product notification requirements (e.g., CPNP or SCPN).
Conducting post-market surveillance to address safety concerns.
Blanka’s Role in Compliance Support
Blanka works with trusted manufacturing partners in Canada and the United States who follow rigorous regulatory compliance standards, such as meeting FDA and GMP requirements. Despite this, Blanka does not act as the EU/UK Responsible Person for compliance. Instead, Blanka provides direct support to the designated RP by offering supporting documentation upon request.
Supporting Documentation From Blanka
Blanka caters to the needs of the brand’s RP by providing relevant information, such as:
Product ingredient lists.
Manufacturing certifications.
Safety assessment documentation.
Merchants or brand owners can request specific documentation from Blanka to help their RP meet the compliance requirements. However, Blanka does not supply a single centralized certification or generate PIF/CPSR directly.
Steps for Requesting Documentation From Blanka
To ensure seamless regulatory compliance support, follow these steps:
Confirm the specific documentation needs for your market (e.g., PIF, CPSR).
Identify your designated Responsible Person (RP).
Contact the Blanka support team or account representative to request relevant supporting documents.
Provide any additional details required by Blanka to ensure accurate provision of documents.
Limitations of Blanka’s Services
While Blanka provides extensive support, it is important to note:
Blanka does not act as the Responsible Person for any brand.
Compliance documentation is supplied only upon request and is intended to assist the RP in their regulatory duties.
Conclusion
By partnering closely with trusted manufacturers and offering documentation support, Blanka helps streamline compliance efforts for brand owners. However, ultimate accountability for compliance lies with the designated Responsible Person, who must manage all regulatory requirements, including preparing and maintaining the Product Information File (PIF/DIP) and other essential compliance actions. For further inquiries or document requests, contact Blanka’s support team.