In short
A fragrance compliance file gathers the evidence for one product and market, so every conclusion can be traced to a dated source, each document has an owner, and a change immediately shows what must be reviewed. Your Level 10 review was a one-time assessment. A file is what keeps that assessment alive. This track goes further, and it's still not legal or safety advice: a named, qualified person has to confirm what applies to your product.
What you will learn
- Structure a file so that claims trace to evidence
- Link each document to an owner, version and review date
- Map what a formula or supplier change would invalidate
Before this lesson: Running a Compliance Review
Scope of this track
As an independent learner, you can build structure, calculations, records and quality routines. You can't sign a safety report or confer legal compliance. Regulations here are described as of November 2026, and each lesson says when and where. Check the primary source before acting.
A file structure
| Section | Contents | Likely owner |
|---|---|---|
| A. Product identity | Name, version, type, use, market, responsible party | Brand |
| B. Formula | Exact formula and fragrance compound records | Perfumer, formulator |
| C. Raw materials | SDS, specifications, certificates, composition data | Suppliers, you |
| D. Fragrance compliance | IFRA calculations or certificate, allergen list, phototoxicity | Perfumer, supplier |
| E. Safety | Safety assessment or substantiation | Qualified assessor |
| F. Stability and packaging | Reports, compatibility | Formulator, laboratory |
| G. Manufacturing | Method, GMP statement, batch records | Manufacturer |
| H. Label and claims | Artwork, ingredient list, claim evidence | Brand, assessor |
| I. Market duties | Notification, registration, importer details | Responsible party |
| J. After sale | Complaints, adverse events, recalls | Responsible party |
| K. Change log | Every change, its reason and its review | File owner |
The index does the work
| Document | Version or date | Source | Applies to | Owner | Review by | Status |
|---|---|---|---|---|---|---|
| Lemon oil SDS | Rev. 3, stated date | Supplier | Lot range | You | Next purchase | Held |
Statuses might be held, requested, missing or needs a qualified person. Don't use "done" for anything that can age.
A change-impact matrix
| Change | Formula | IFRA | Allergens | Stability | Safety | Label | Notification |
|---|---|---|---|---|---|---|---|
| Formula line | Yes | Yes | Yes | Likely | Yes | Possibly | Possibly |
| Supplier or grade | Record | Check | Yes | Possibly | Possibly | Possibly | Possibly |
| Dose | Yes | Yes | Yes | Likely | Yes | Possibly | Possibly |
| Packaging | No | No | No | Yes | Possibly | Possibly | Possibly |
| New amendment or law | Possibly | Yes | Possibly | If reformulated | Possibly | Possibly | Possibly |
| New claim | No | No | No | No | Possibly | Yes | Possibly |
| New market | Possibly | Check | Yes | No | Yes | Yes | Yes |
Retention and access
Know how long you must keep what. In the EU, Article 11 requires the file to be kept for 10 years following the date on which the last batch was placed on the market, and GB guidance is similar. Other markets differ, and the guide on keeping formula records compares them. Keep confidential formula details protected, and keep a backup. Make sure that the responsible party, if different from you, has what they need when an authority asks.
Good file habits
- One current version of each document, with superseded ones archived.
- A date on each conclusion.
- A person's name on each decision.
- No copied certificates for materials you no longer buy.
- A calendar date to check on sources, such as the next IFRA notification, expected in January 2027.
Practical exercise: Build the skeleton of a file
- Choose one fragrance, one product type and one market.
- Build the file index, listing all the documents you'd need, even those you don't yet have.
- Mark each with status, owner and review date.
- Build a change-impact matrix, and adjust the example to your product.
- Run a drill: suppose your citrus supplier changes origin. Follow the matrix, and list exactly what you'd do.
You have done this well if a missing document is visible at a glance, each row has an owner, and your drill ends in a concrete list.
Common mistakes
- Collecting paper with no index. You can't see what's missing.
- Letting documents age silently. Set review dates.
- Treating the file as approval. It's the evidence for others to assess.
Key terms
- Product information file
- The EU and GB term for the documentation that must be kept available for a cosmetic product, including its safety report and evidence for its claims.
- Change-impact matrix
- A table showing which documents must be reviewed when a given item changes, such as the formula or a supplier.
Knowledge check
Written and reviewed by the RUŌOD Lab team. This is general education, not legal, regulatory, medical or safety advice. Example dilutions and exercises are for learning, are not validated products, and have not been safety-assessed. Completing a lesson confers no qualification. How we check these lessons.