Selling Cosmetics in the EU: The Responsible Person's File, From Formula to Market
A named EU Responsible Person, a signed safety report and a complete Product Information File come before any sale.
In Short
- The RP must be in the EU.
- Keep the PIF ten years.
- EN ISO 22716 gives presumed GMP.
The Cosmetics Manufacturing Guide
The right formula. Stable batches. Traceable jars.
- MoCRA, EU 1223/2009 and Canada
- Formulas, water and materials
- Phases, bulk tests and microbiology holds
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UltimateFree guide
The Cosmetics Manufacturing Guide
The right formula. Stable batches. Traceable jars.
Every cosmetic placed on the EU market needs a named Responsible Person who answers for compliance. Most obligations come back to one file: the Product Information File, built on a safety assessment and kept available to authorities. Sources checked 4 Oct 2026.
The Responsible Person
Article 4 requires a legal or natural person established in the EU to be designated as Responsible Person for each product. They ensure compliance with the Regulation's obligations, from safety to labelling.
More on the Responsible Person
Brands outside the EU usually appoint one by written mandate.
Safety Assessment and Report
Article 10 and Annex I require a cosmetic product safety report before the product is placed on the market. Part A holds safety information such as formula, physical and chemical characteristics, microbiological quality, stability, impurities and exposure.
More on safety Assessment and Report
Part B is the assessor's conclusion, signed by a qualified safety assessor.
The Product Information File
Under Article 11 the PIF contains the product description, the safety report, a description of the manufacturing method with a GMP statement, proof of claimed effects and data on any animal testing. It is kept for ten years after the last batch was placed on the market, at the Responsible Person's address.
What goes in the Product Information File
GMP and the Batch Record
Article 8 says manufacture must follow good manufacturing practice, with compliance presumed when done to the relevant harmonised standard, EN ISO 22716. In practice that means controlled formulas, approved raw materials, batch records, in-process and release checks, and traceable lots.
Notification, Labels and After-Market
Before placing a product on the market the Responsible Person notifies it through the Cosmetic Products Notification Portal under Article 13. Labels follow Article 19, including the ingredient list and fragrance allergens where required.
Who does what
| Task | Who |
|---|---|
| Safety report Part B | Qualified safety assessor |
| CPNP notification | Responsible Person |
| Batch release | Manufacturer's quality function |
| Serious undesirable effects | Responsible Person reports to authority |
- Safety report Part B
- Who
- Qualified safety assessor
- CPNP notification
- Who
- Responsible Person
- Batch release
- Who
- Manufacturer's quality function
- Serious undesirable effects
- Who
- Responsible Person reports to authority
More on notification, Labels and After-Market
Serious undesirable effects are reported to the national authority under Article 23.
Questions
Can a non-EU brand be the Responsible Person?
No. The Responsible Person must be established in the EU. A non-EU brand designates one, often an importer, distributor or service provider.
How long is the PIF kept?
Ten years after the last batch of the product was placed on the market.
Is EN ISO 22716 mandatory?
The Regulation requires GMP. Following EN ISO 22716 gives a presumption of conformity; other approaches must show equivalent results.
Does V5 write the safety report?
No. V5 keeps formula revisions, raw material lots and specifications, batch records, test results and complaints. A qualified assessor writes and signs the safety report; your Responsible Person decides.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
Keep reading
Global Cosmetics Regulatory Readiness: EU, UK, US, ISO 22716
EU Fragrance Allergen Labelling: Regulation 2023/1545 Readiness
Cosmetic Microbiological Quality (ISO 17516) Readiness Guide
Cosmetic Stability and Preservative Efficacy (ISO 11930)
ISO 22716 Cosmetics GMP Guide: Structure, EU Role and Practical Controls- MoCRA Guide: US Cosmetics Registration, Listing, Adverse Events and GMP Status