Compliance

Navigating EU regulations: GPSR documentation support for Private Label brands

Launching an intimate wellness product in today’s regulatory environment isn’t just about having a great formula. It’s about ensuring it meets evolving safety standards across international markets. With the European Union’s General Product Safety Regulation (GPSR) now in full effect, brands must be more vigilant than ever. At Cobeco Pharma, we make compliance easy by offering robust GPSR documentation support as part of our private label manufacturing services.

Whether you’re developing intimate lubricants, wash gels, or food supplements, we handle the heavy lifting so your product is fully aligned with EU regulations.

Why GPSR matters

The GPSR (EU Regulation 2023/988) replaces the General Product Safety Directive (GPSD) and introduces stricter requirements for non-food consumer products, including many intimate wellness items.

Key changes include:

  • Obligations for online marketplaces

  • Mandatory safety documentation and risk assessments

  • Enhanced product traceability and incident reporting

  • Appointment of a responsible person for products sold in the EU

Failing to comply isn’t just a regulatory risk. It can result in costly recalls, reputational damage, and halted sales. That’s why working with a manufacturing partner who understands the GPSR inside and out is crucial.

How we support you with GPSR documentation

When you choose us as your private label manufacturing partner, GPSR compliance is built into our process:

  • Risk assessments & safety files
    We conduct and provide documented product-specific risk assessments, covering all GPSR-required areas, from chemical safety to usage scenarios.
  • Technical documentation dossiers
    Our team compiles the complete technical file for each SKU—including ingredients, specifications, safety testing, and more—so you’re always audit-ready.
  • Label & claims compliance
    We review your artwork and product claims against GPSR, CPNP (Cosmetic Product Notification Portal), and other applicable regulations to ensure you’re not just compliant, but market-ready.
  • Authorized representative support
    Don’t have a legal entity in the EU? We help you identify or partner with qualified Responsible Persons who can act on your behalf for GPSR obligations.
  • Ongoing regulatory updates
    Our in-house compliance team monitors regulatory changes and proactively advises clients on required adjustments, ensuring you stay ahead of the curve.

Certifications that back our promise

Our facilities are fully certified to support the highest standards of compliance, including:

  • ISO 13485

  • GMP (Good Manufacturing Practices)

  • HACCP

  • CPNP Registration Support

  • SEDEX & NCV Audited

  • FSSC 22000 Certified (for applicable ingestibles)

Summary: Why GPSR compliance starts with the right manufacturing partner

By choosing Cobeco Pharma as your private label partner, you gain:

  • Peace of mind with full GPSR documentation support

  • Ready-to-submit technical files for EU compliance

  • Packaging and label claim validation

  • EU market readiness—even without a physical presence

  • Access to a regulatory team that knows wellness inside and out