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Many brands preparing an oral care product for the EU market eventually reach the same question: who submits the CPNP notification, and what role does the manufacturer actually play?
While the notification itself is handled by the brand’s appointed Responsible Person, preparing the information needed to support that process begins much earlier during product development.
This often creates confusion because manufacturers, brands, and Responsible Persons all contribute different parts of the project. Understanding those responsibilities early helps prevent delays and makes communication much more efficient as the product moves toward commercial production.
This guide explains what an oral care manufacturer should support during CPNP preparation, where that support ends, and which responsibilities remain entirely with the brand and its Responsible Person.
The Cosmetic Products Notification Portal (CPNP) is the EU’s system for notifying cosmetic products before they are placed on the market. Submitting a notification does not mean the product has been approved, certified, or endorsed by an EU authority.
For oral care brands, the more important question is not how the portal works, but who prepares the information and who submits it. The manufacturer supports the technical information needed for the project, while the Responsible Person remains responsible for the notification itself.
For an outsourced oral care manufacturing project such as those discussed in this guide, the brand’s designated Responsible Person (RP) is responsible for submitting the CPNP notification before the product is placed on the EU market.
ORALABX’s role as the manufacturer is different but equally important. Throughout product development, we prepare and provide the agreed formulation-related technical information and supporting documentation that the Responsible Person may need to complete the notification accurately and on time.
While we support the process, the notification itself remains the responsibility of the designated Responsible Person for the project.
| Manufacturer Support | Brand / Responsible Person Responsibility |
| Prepare product and formulation information generated during development. | Submit the CPNP notification before the product is placed on the EU market. |
| Provide ingredient information and available technical documentation within the agreed project scope. | Ensure the notification is complete and accurate. |
| Coordinate manufacturing-related documentation and respond to technical information requests where applicable. | Review product claims, labelling, and destination-market compliance. |
| Communicate with the brand or its regulatory partners when technical clarification is required. | Maintain responsibility for regulatory obligations associated with placing the product on the market. |
For an outsourced OEM project, the distinction is that the manufacturer prepares the agreed technical information that supports the notification, while the designated Responsible Person submits the notification and assumes responsibility for the associated regulatory obligations.
Understanding this division early helps brands plan documentation requests, avoid unnecessary delays, and keep development moving efficiently.
Preparing for CPNP notification requires information from both the manufacturer and the brand or Responsible Person. Some details come directly from product development, while others depend on regulatory decisions made before the product enters the EU market.
Understanding who typically provides each type of information helps buyers plan documentation requests earlier and reduces unnecessary delays once the Responsible Person begins preparing the notification.
| Information Used During Preparation | Typically Provided By | Example |
| Frame formulation information | Manufacturer | Formulation or composition information prepared in the applicable format to support notification preparation where required. |
| Supporting formulation information requested by the Responsible Person | Manufacturer | Relevant formulation and ingredient information generated during development and provided when required to support the Responsible Person’s notification preparation. |
| CMR or nanomaterial information (where applicable) | Manufacturer | Technical information relating to ingredients used in the formulation. |
| Product label and artwork | Brand / Responsible Person | Product name, claims, intended use, and final label content approved for the destination market. |
| Product claims | Brand / Responsible Person | Marketing claims selected for the product and reviewed for market compliance. |
| Final notification and regulatory review | Responsible Person | Completion of the CPNP notification and associated regulatory responsibilities. |
Not every project will require the same information. For example, nanomaterial information is only relevant if the formulation contains ingredients that meet the applicable regulatory definition.
Likewise, the manufacturer prepares formulation-related technical information, while the brand and Responsible Person remain responsible for how the product is ultimately presented and notified in the intended market.
Preparing a CPNP notification may require formulation or composition information in the applicable format. For toothpaste and mouthwash projects, the manufacturer is typically best positioned to prepare accurate formulation-related technical information because it is generated during formulation development and manufacturing.
This information may include the composition details agreed for the project together with other formulation-related technical documentation requested by the Responsible Person during notification preparation. The Responsible Person then determines how that information is used to complete the CPNP notification in accordance with the applicable requirements.
If the approved toothpaste or mouthwash formulation changes after this information has been prepared, the manufacturer should communicate the updated formulation details so the Responsible Person can review whether the notification information also needs to be updated before the product is placed on the market.
This is why an experienced oral care manufacturer begins organising formulation-related technical information during development instead of waiting until production has been completed. Early preparation helps support a smoother transfer of information between the manufacturer and the Responsible Person.
Preparing for CPNP notification is an ongoing process that runs alongside product development. As formulation and packaging decisions become final, technical information moves from the manufacturer to the brand and its Responsible Person to support notification planning.
Understanding when these handoffs typically occur helps brands request the right information at the right stage and reduces unnecessary delays later in the project.
| Project Stage | Typical Manufacturer Handoff |
| Initial project discussion | Confirm the destination market, notification expectations, and the technical information likely to be required. |
| Formula development | Prepare formulation-related technical information, including formulation or composition information that may be requested by the Responsible Person during CPNP preparation. |
| Sampling and product evaluation | Finalise formulation details, update technical information where required, and document approved formulation changes. |
| Pre-production preparation | Provide the completed technical documentation agreed for the project so the Responsible Person can prepare for notification. |
| Commercial production | Confirm that the final production formulation matches the information prepared for notification and provide agreed production-related documentation where applicable. |
Some technical information cannot be completed until the formulation and packaging have been approved. However, manufacturers should begin preparing formulation and documentation during development instead of waiting until production is complete.
This gives the Responsible Person more time to review the information, identify any gaps, and prepare the notification before the product is ready for market.
Brands planning to sell toothpaste or mouthwash in both the EU and the UK should be aware that the UK uses a separate Submit Cosmetic Product Notification (SCPN) system. Although the notification systems are different, the responsibility split remains much the same.
The manufacturer supports the project by providing formulation and technical documentation, while the brand and its Responsible Person remain responsible for completing the notification and meeting the applicable regulatory requirements for the UK market.
CPNP preparation rarely slows down because of the notification portal itself. More often, delays begin much earlier when technical information, formulation decisions, or documentation timelines have not been agreed before the Responsible Person starts preparing the notification.
The Responsible Person may need formulation-related information before commercial production begins. Delays can occur when these requirements are communicated to the manufacturer too late, or when the necessary technical information is not ready at the stage when notification preparation begins.
Brands should therefore confirm early what formulation information the Responsible Person will require, when it is expected to become available, and how approved formulation changes will be communicated during development. Aligning these expectations before the final production stage gives the manufacturer time to prepare the agreed technical information and helps prevent avoidable delays in CPNP preparation.
Changes to a toothpaste or mouthwash formulation after technical documentation has already been prepared may require parts of that information to be reviewed or updated.
Whenever formulation changes are approved, brands should notify both the manufacturer and the Responsible Person as early as possible to keep the project aligned.
Delays can also occur when the manufacturer and the brand have different expectations about what information will be provided and when it will be available.
A simple discussion at the beginning of the project can prevent this. Confirming documentation requirements, handoff dates, and project responsibilities early helps the notification process run more smoothly.
Many notification delays observed from the manufacturing side begin with incomplete project preparation rather than the CPNP portal itself. Clear communication, realistic timelines, and early documentation planning help brands move through notification with fewer last-minute issues.
Submitting a CPNP notification through the European Commission’s portal is free. However, brands should still budget for activities that support market entry, such as appointing a Responsible Person, safety assessment, label review, or any reformulation required before notification. The manufacturer’s role is to provide the agreed technical information needed to support the process.
It depends on how the variants differ. Differences in the formulation, product identity, packaging or presentation where relevant, or other information affecting the notification may need to be considered. The Responsible Person should assess each variant against the applicable CPNP notification requirements, while the manufacturer provides the formulation and technical information needed to support that assessment.
Formula changes may require the notification information to be reviewed and updated. For this reason, manufacturers and Responsible Persons should be informed of approved formulation changes as early as possible so the technical documentation and notification information remain consistent.
Yes. A brand can appoint a different Responsible Person if needed. This is an administrative and regulatory matter managed by the brand and the Responsible Person. A change of Responsible Person does not necessarily change the manufacturer-generated formulation information, although the associated documentation and notification arrangements may still require administrative review or transfer.
Preparing for CPNP notification starts long before the Responsible Person submits the final notification. It begins with accurate formulation information, organised technical documentation, and clear communication between the manufacturer, the brand, and the Responsible Person throughout product development.
At ORALABX, we support brands by preparing the technical information generated during formulation, sampling, and manufacturing within the agreed project scope. This helps Responsible Persons access the information they need while keeping product development and notification preparation aligned.
If you’re planning to launch a toothpaste or mouthwash brand in the EU, contact our team before commercial production begins. We’ll help you prepare the formulation and technical information needed to support a smoother CPNP preparation process while keeping your project on track for manufacturing.
Share your product type, target market, estimated volume and launch timeline. We will review the project scope and recommend the appropriate development path.
Best suited to brands, importers and distributors planning scalable commercial production.