Safety dossier

Pick a saved recipe and the page writes out what a safety assessor needs from you: the composition, the ingredient list, the fragrance’s paperwork, the suppliers and lots, the method and the batches made, in the order of Annex I of Regulation (EC) No 1223/2009. What your records do not hold, you write in below. Anything left empty prints as a line to fill in.

Details for this product

What your records cannot know. It is saved to your account with this recipe, and anything left empty prints as a line to write on.

Responsible person

The person or company that places the product on the market, whose name and address go on the label. The same for every product.

Name

Address

Description of the product

Size and packaging

Intended users

2. Physical/chemical characteristics and stability

Appearance

pH (1 % solution)

Stability in storage

Keeps unopened, months from making

Period after opening, months

Stability checks

Samples kept from a batch and looked at over time: at room temperature, somewhere warm, and in the light. Note what you see, smell and measure, and when.

3. Microbiological quality

Counts or a challenge test, or why the product is low risk

Challenge tests

A laboratory’s test of how well the preservative works, usually to ISO 11930. Keep the report with the dossier.

4. Impurities, traces, information about the packaging material

The suppliers and lots come from the stock page, for batches that took their ingredients from stock.

Purity and impurities

Packaging material

5. Normal and reasonably foreseeable use

How it is used Left empty, the dossier uses the sentence shown.

6. Exposure to the cosmetic product

Site of application

Surface area

Amount applied

Duration and frequency

Exposure route

Exposed population

Default exposure values for shower gel and hand wash soap, for a first-tier assessment. The assessor decides which apply. Source: SCCS Notes of Guidance, 12th revision

9. Undesirable effects and serious undesirable effects

Every report of a reaction, however slight, with what was done.

10. Information on the cosmetic product

Other relevant information, such as studies with volunteers

The safety assessment

Safety assessor

Date of the assessor’s report

What this is

Before a cosmetic goes on sale in the EU, a qualified safety assessor writes a safety report for it, and the responsible person keeps it in the product information file. Part A of the report is information and Part B is the assessment. This page fills in Part A as far as your records go, so the assessor starts from your numbers rather than a blank form.

It is not a safety report and it does not make a product compliant. The composition is recomputed from the recipe every time you build it, so it always matches what you saved. Check it against what you actually weighed.

Regulation (EC) No 1223/2009 on EUR-Lex