PIF preparation support
We help assemble the technical product information needed for the Product Information File according to the agreed project scope.
Regulatory support
EU & UK Cosmetic Regulatory Support
A finished cosmetic formula is not ready for sale until the required safety, information, notification and labelling steps are complete for the destination market. We support clients through the technical documentation and testing around that process while keeping the legal role of the designated Responsible Person clear.
- EU CPNP notification route under Regulation (EC) No 1223/2009
- Great Britain SCPN notification through the UK service before market placement
- PIF + CPSR Product information and cosmetic safety documentation
- Testing support Stability, compatibility, challenge and specialised testing as required
Notification, safety assessment and the Product Information File are different parts of compliance
For products placed on the EU market, the Cosmetic Products Notification Portal (CPNP) is the electronic notification system used by the Responsible Person or, in defined circumstances, distributors. The Product Information File is a separate body of documentation that must be kept available by the Responsible Person.
For products placed on the Great Britain market, notification is made through the UK Submit Cosmetic Product Notifications service (SCPN). The market route, Responsible Person and labelling requirements must therefore be defined before launch documentation is finalised.
Capabilities
Where Tsilkov supports the regulatory workflow
Safety assessment / CPSR coordination
The cosmetic safety assessment must be performed by a suitably qualified assessor. We support the data package and coordinate the process where included.
EU CPNP support
For EU products, we support the information required for CPNP notification by the applicable Responsible Person.
Great Britain SCPN support
For products placed on the Great Britain market, we support the product data needed for notification through the SCPN route.
Testing coordination
Stability, compatibility, challenge and additional specialised testing are aligned with product type, claims and market requirements.
Label and artwork review
Ingredient naming, mandatory particulars, Responsible Person details, warnings and other label elements are reviewed within the agreed regulatory scope.
Process
A practical regulatory route from approved formula to launch
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Define the market
We confirm whether the product is intended for the EU, Great Britain, Northern Ireland or another market because the route is not identical.
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Confirm the Responsible Person
The legal Responsible Person arrangement is identified before notification and final label details are completed.
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Complete testing
The required stability, compatibility, challenge and other supporting tests are completed according to the product and claims.
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Prepare safety information
The technical data package is prepared for the qualified safety assessor and CPSR process.
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Assemble the PIF
Product description, CPSR, manufacturing/GMP information, claims support and other required records are compiled within the applicable scope.
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Notify and launch
The applicable Responsible Person completes the required market notification and ensures the final label and records are compliant before sale.
Technical detail
What buyers usually need to know before the project starts
European Union route
Regulation (EC) No 1223/2009 requires an EU Responsible Person for cosmetic products placed on the EU market. The Responsible Person must ensure that the product is safe, keep the Product Information File available and submit the required product information through CPNP before the product is placed on the market.
- Qualified cosmetic safety assessment and CPSR
- Product Information File kept by the Responsible Person
- CPNP notification before market placement
- Compliant ingredient list and mandatory label information
- Evidence supporting cosmetic claims where applicable
- Good Manufacturing Practice information
Great Britain route
Products made available to consumers in Great Britain must have an appropriate UK Responsible Person and be notified to the Office for Product Safety and Standards through the Submit Cosmetic Product Notifications service before being made available to consumers.
- UK Responsible Person arrangement
- PIF and safety information
- SCPN notification
- Required product and packaging information
- Great Britain labelling requirements
- Ongoing obligations for adverse effects and record maintenance
What Tsilkov does - and what the Responsible Person does
Tsilkov can support testing, technical documentation, safety-assessment coordination, label review and notification data according to the agreed project scope. The legal obligations of the Responsible Person remain with the entity designated for the relevant market unless a separate written arrangement explicitly assigns a permitted role.
Manufacturing and compliance ISO 22716 cosmetic Good Manufacturing Practices
Regulatory documentation is stronger when the manufacturing record is controlled
Our quality system, manufacturing records and product-development information sit within the same organisation that supports the regulatory file. That makes it easier to connect formula, process, testing, packaging and batch information when documentation is prepared or updated.
Talk to the owners Good to know
Cosmetic Regulatory Support FAQs
Is CPNP the same as the Product Information File?
No. CPNP is the EU electronic notification system. The PIF is the underlying product-information dossier that the Responsible Person must keep available.
Who prepares the CPSR?
The cosmetic safety assessment and CPSR must be completed by a suitably qualified safety assessor. Tsilkov can support the technical data package and coordinate the process where included in the project scope.
Who submits the CPNP notification?
The EU Responsible Person is responsible for the required CPNP notification, although Tsilkov can support preparation of the product information and process according to the agreed arrangement.
What system is used for Great Britain?
Products placed on the Great Britain market are notified through the UK Submit Cosmetic Product Notifications service, commonly referred to as SCPN.
Is Northern Ireland the same as Great Britain?
No. Northern Ireland follows a different cosmetics market route under the applicable post-Brexit arrangements, so the destination should be identified separately before launch.
Can you review our label artwork?
We can review cosmetic label information within the agreed regulatory scope, but the final legal responsibility depends on the designated Responsible Person and destination market.
Do you arrange product testing?
We support stability, compatibility and challenge testing and coordinate specialised or accredited external testing where required by the product, claims or market.
Tell us what you want to make
Share the product, quantity, packaging idea or manufacturing challenge. One of the owners will reply personally.