The topic is short and compact
Every product needs a responsible person based in the EU who is legally liable.
The product information file must remain available for ten years after the last batch.
The CPNP notification is the final step and requires a completed safety report.
Every cosmetic product placed on the EU market must be assigned to a designated responsible person who is established in the EU. They are the legal point of contact for the authorities and are liable for the conformity of the product.
This role is not automatically the manufacturer. For private labels, it is usually the brand itself. If importing from a third country, the importer or a commissioned service provider must assume the role. The assignment must be regulated in writing before development begins.
An EU base is mandatory.
Maintains the product information file and keeps it available for authorities.
Responsible for labeling, notification, and market surveillance.
The responsible person
Every cosmetic product placed on the EU market must be assigned to a designated responsible person who is established in the EU. They are the legal point of contact for the authorities and are liable for the conformity of the product.
This role is not automatically the manufacturer. For private labels, it is usually the brand itself. If importing from a third country, the importer or a commissioned service provider must assume the role. The assignment must be regulated in writing before development begins.
An EU base is mandatory.
Maintains the product information file and keeps it available for authorities.
Responsible for labeling, notification, and market surveillance.
The product information file
The product information file is the central dossier. It contains the qualitative and quantitative formulation, specifications and safety data of the raw materials, the manufacturing description with proof of Good Manufacturing Practice, the stability and microbiological data, as well as evidence for every advertising claim.
It must remain available for ten years after the last batch has been placed on the market and must be accessible at the request of the authorities. In practical terms, this means: it is created during development, not after. Anyone who compiles it retrospectively regularly finds that tests are missing.
Quantitative formulation with raw material specifications.
Manufacturing description and GMP proof according to ISO 22716.
Stability, compatibility and microbiological data.
Evidence for each claimed effect.
The Safety Report: Part A and Part B
The safety report is the core of the product information file. Part A compiles the data: formulation, toxicological profiles of the raw materials, exposure assessment, impurities, stability and microbiological quality. Part B contains the assessment and the conclusion.
Part B may only be prepared by an appropriately qualified person. The quality of Part B depends entirely on the completeness of Part A: missing data lead to more conservative assumptions that limit efficacy claims, or prevent the completion of the assessment. The scope of testing is described in stability and safety testing.
Part A: complete data collection.
Part B: assessment by a qualified person.
Exposure assessment depending on application, quantity and target group.
The CPNP notification
Before being placed on the market, the product is registered in the European notification portal CPNP. The product category, formulation in the required form, details of the responsible person, labeling, and a packaging image are notified.
The notification is the final step and requires a completed safety report. It is not an approval: there is no official clearance; the responsibility remains entirely with the responsible person.
Takes place before placing on the market, after completion of the safety report.
Not an approval, but a registration.
In the event of a formulation or labeling change, the notification must be updated.
Labeling
The regulation stipulates what must appear on the packaging: name and address of the responsible person, nominal filling quantity, minimum durability or period of use after opening, special precautionary measures, batch number, intended use, and the complete list of ingredients according to INCI in descending order.
Common sources of error are an incomplete or incorrectly sorted INCI list, a missing indication of durability after opening, and advertising claims without proof. The latter is the most common reason for complaints. Details on this in Advertising claims in the EU.
INCI complete and correctly sorted in descending order.
Indicate durability or period of use after opening.
Batch number for traceability.
Sequence and schedule
The sequence cannot be freely chosen. Tests require a final formulation in final packaging, the safety report requires completed tests, and the notification requires the safety report. Any open decision at the beginning postpones the end by the same period of time.
Realistically, it takes about four to five months from the final approval of the formulation and packaging until the product is marketable. Anyone who only starts the regulatory process after development loses this additional time. The temporal relationships are illustrated in Shorten Time-to-Market.
Define packaging bindingly before the start of testing.
Define advertising claims before test planning.
Book production slot bindingly only after test results are available.
More useful links
FAQ
Who is the responsible person?
A natural or legal person based in the EU who is liable for the conformity of the product. In the case of private labels, this is usually the brand itself; in the case of imports from third countries, the importer or an authorized service provider. This assignment should be clarified in writing before the start of development.
What belongs in the product information file?
The quantitative formulation, raw material specifications and safety data, the manufacturing description with GMP proof according to ISO 22716, stability, compatibility and microbiological data as well as evidence for each claimed effect. It must remain available for ten years after the last batch.
Is the CPNP notification an authorization?
No. The CPNP is a notification portal, not an authorizing authority. No substantive review takes place and no approval is granted. The responsibility for safety remains entirely with the responsible person.
Who is allowed to prepare the safety report?
Part A, the data collection, can be compiled by the development partner. Part B, the actual evaluation and conclusion, may only be prepared and signed by an appropriately qualified person. The quality of Part B depends directly on the completeness of Part A.
What are the most common labeling errors?
An incomplete or incorrectly ordered INCI list, a missing indication of the period after opening, and advertising claims without proof. The latter is the most common reason for complaints, because statements are often only determined after the packaging design has been finalized.
How long does it take until it is marketable?
Approximately four to five months from the final release of the formulation and packaging: twelve weeks of stability testing, parallel microbiological tests, followed by the safety report and CPNP notification. This sequence is mandatory because each step is a prerequisite for the next.
