Ten of the EU PIF's 14 headings are the factory's
What delays an EU Responsible Person contract is rarely the fee. The safety report runs to fourteen headings, only four of which the assessor signs, and the other ten stay empty until the Korean manufacturer sends data. Retention runs ten years from the last batch.
An EU Product Information File has 5 parts, and the safety report inside it splits into 14 headings. Only the 4 headings of Part B carry the qualified assessor's signature; Part A's 10 are formulation, stability, microbiological and impurity data that nobody but the manufacturer holds. Retention runs 10 years from the date the last batch was placed on the market.
What stalls is the data, not the fee
A European Responsible Person quote usually fits on one page: monthly retainer, CPNP notification, label review, two to three weeks. The first notification then takes two or three months.
The jam is documentary. Regulation 1223/2009 builds the Product Information File from five parts, and the safety report inside it splits into fourteen headings in Annex I. Four of those headings are the ones an agency can actually produce; the rest wait on the Korean factory and the brand.
Five parts, three owners
Article 11(2) lists what the file holds. Two parts are factory documents, two belong to the brand, one is the assessment itself.
| PIF content, Article 11(2) | Who supplies it |
|---|---|
| (a) description allowing clear attribution | brand |
| (b) cosmetic product safety report | assessor, on factory data |
| (c) manufacturing method and GMP statement | factory |
| (d) proof of claimed effect, where justified | brand |
| (e) animal testing data | factory and suppliers |
Item (d) is conditional. It applies where the nature or the effect of the product justifies it, so a wrinkle claim pulls in substantiation while a plain hydrating toner sits at a different level.
Item (e) catches Korean brands out. The text covers testing by the manufacturer, its agents or its suppliers, and says so including tests carried out to meet a third country's legal requirements. A product with a Chinese hygiene licence behind it carries that history into the file.
Only four headings need a signature
Annex I runs ten headings in Part A and four in Part B. Part B is what the assessor writes and signs.
Those four are the conclusion, the labelled warnings and instructions under Article 19(1)(d), the reasoning, and the assessor's credentials with the approval itself. The reasoning heading carries a specific assessment for children under three and for external intimate hygiene products, which is why a kids line or a feminine wash lengthens the report rather than sharing it.
The qualification sits in Article 10(2): a diploma from a university course in pharmacy, toxicology, medicine or a similar discipline, or a course a Member State recognises as equivalent. A researcher's name on a Korean test report is not a substitute.
Where Part A goes empty
All ten Part A headings start from factory records. The assessor calculates two of them, the exposure figures, and even that calculation needs the formulation and the packaging.
| Part A heading | Why it sits empty |
|---|---|
| 1 quantitative and qualitative composition | supplier gives ranges, not exact levels |
| 2 physical/chemical characteristics, stability | accelerated only, no long-term study |
| 3 microbiological quality | preservative challenge test missing |
| 4 impurities, traces, packaging material | no container compatibility data |
| 5–7 use conditions and exposure | assessor's calculation; needs formula, pack |
| 8 toxicological profile of substances | spec sheet only, no toxicology dossier |
| 9 undesirable effects | prior sales history not compiled |
| 10 information on the cosmetic product | existing studies not inventoried |
Heading 4 is the slow one. Packaging compatibility testing cannot start until the container is locked, so a late design decision pushes the whole file. Heading 8 is the other trap: Korean ingredient distribution runs on a one-page specification, while a European assessor wants a toxicological profile per substance, and going back to the supplier for that takes weeks.
Translation, GLP and ten years of storage are costs
Article 11(3) asks the Responsible Person to keep the file readily accessible at the address shown on the label, in a language the authorities of the Member State holding it easily understand. Handing over a stack of Korean-language reports books a translation cost nobody quoted.
Non-clinical safety studies carry one more condition. Article 10(3) requires studies carried out after 30 June 1988 to follow the Community principles of good laboratory practice, or international standards recognised as equivalent. A cheap report that falls outside GLP has to be repeated, so ask about GLP recognition before signing with a testing house.
Article 5(3) is worth reading alongside. On a reasoned request from a national authority, the Responsible Person has to hand over everything needed to show conformity, again in a language that authority easily understands. Most agency contracts pass that support obligation back to the brand.
Retention does not start at notification. It runs ten years from the date the last batch went on the market, and Article 10(1)(c) also asks for the report to stay current as new information appears after launch. The file is maintained, not filed and forgotten.
The appointment itself is written. Article 4 has a manufacturer outside the Community designate the Responsible Person by written mandate, with written acceptance in return. Two lines in that mandate — whether Part A support is included, and whether the brand receives a copy of the file on termination — save rebuilding it from scratch when the distributor changes.
In short
- Five parts in the PIF, fourteen headings in the safety report. The agency produces four of them.
- Part A's ten headings begin with factory data. Packaging compatibility and per-substance toxicology take the longest.
- Put translation and GLP recognition in the first budget. Added later, they move the launch date.
- Retention is ten years from the last batch, at the Responsible Person's address on the label. Ask for a file-copy clause in the mandate.
For what is moving on the shelf right now, see today’s ingredient signal, and for category price bands and cost structure, the product planner.
*Sources: Regulation (EC) No 1223/2009, consolidated text of 24 April 2024, Articles 10, 11 and 13 and Annex I — EUR-Lex / the same regulation, Articles 4, 5 and 6 — legislation.gov.uk*
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Questions people ask
Usually it writes Part B and files the CPNP notification. Annex I of Regulation 1223/2009 asks Part A for ten headings covering composition, stability, microbiological quality, impurities and toxicology, and only the manufacturer holds those records. Check in writing whether Part A preparation sits inside the contract.
Article 10(2) sets the qualification. The assessor needs a diploma from a university course in pharmacy, toxicology, medicine or a similar discipline, or a course a Member State recognises as equivalent. A factory lab manager's name does not fill that box.
The data itself travels. Article 11(3) asks for the file in a language the authorities of the Member State holding it easily understand, so translation follows, and non-clinical safety studies have to meet GLP under Article 10(3).
Article 11(2)(e) puts animal testing by the manufacturer, its agents or suppliers into the PIF, and says so including tests run to satisfy a third country's legal requirements. A China hygiene licence history has to appear in the file.
Ten years from the date the last batch was placed on the market. It stays accessible at the Responsible Person's address shown on the label, which means the records sit at that address after the distribution contract ends.