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.
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Every cosmetic product placed on the EU market must be assigned to a designated responsible person who is established in the EU. This person is the legal point of contact for the authorities and is 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 an authorized service provider must assume the role. This assignment must be regulated in writing before development begins.
Establishment in the EU is mandatory.
Maintains the product information file and keeps it available for authorities.
Is responsible for labeling, notification, and market surveillance.
Which steps Labtree takes in this process and what the timeline looks like can be found in the cosmetic development process.
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. This person is the legal point of contact for the authorities and is 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 an authorized service provider must assume the role. This assignment must be regulated in writing before development begins.
Establishment in the EU is mandatory.
Maintains the product information file and keeps it available for authorities.
Is responsible for labeling, notification, and market surveillance.
Which steps Labtree takes in this process and what the timeline looks like can be found in the cosmetic development process.
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 practice, this means: it is created during development, not afterwards. 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 every 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 leads to more conservative assumptions that restrict efficacy claims, or prevents 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 placing 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 authorization, 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 change to the formulation or labeling, the notification must be updated.
Labeling
The regulation prescribes what must be on the packaging: name and address of the responsible person, nominal quantity, minimum shelf life or period of use after opening, special precautionary measures, batch number, purpose of 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 the shelf life 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 shelf life or period of use after opening.
Batch number for traceability.
Sequence and schedule
The sequence is not freely selectable. Testing requires a final formulation in final packaging, the safety report requires completed testing, and the notification requires the safety report. Any open decision at the beginning postpones the end by the same period of time.
Realistic is about four to five months from the final approval of formulation and packaging to marketability. Anyone who starts regulatory affairs only after development loses this additional time. The chronological relationships are shown in Shorten Time-to-Market.
Bindingly define packaging before the start of testing.
Define advertising claims before test planning.
Only book a production slot bindingly after the 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. The allocation of responsibility 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 evidence according to ISO 22716, stability, compatibility and microbiological data as well as evidence for every 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 body. No substantive review is conducted 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 assessment and conclusion, may only be prepared and signed by a correspondingly qualified person. The quality of Part B directly depends on the completeness of Part A.
What are the most common labeling errors?
An incomplete or incorrectly sorted 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 to become marketable?
Approximately four to five months from the final approval of the formulation and packaging: twelve weeks of stability testing, parallel microbiological testing, followed by the safety report and CPNP notification. This sequence is mandatory because each step is a prerequisite for the previous one.
