Cosmetic product safety assessment: who carries it out, in six steps.

The Regulation asks for every cosmetic product to be safe for human health in normal and reasonably foreseeable use. The safety assessment is the work that shows it. Its result is a single report in two parts: the cosmetic product safety report, or CPSR.

Three parties share the work. Only one of them may sign the assessment.

Annex I, Part B ends with the assessor’s name and address, proof of their qualification, and the date and signature.

The report is the last thing written. Most of the work is getting the formula, the documents and the tests ready for the assessor.

1. 01The formula

   Every ingredient by INCI name, with its percentage and function, checked against the annexes: prohibited, restricted, colourants, preservatives, UV filters. Formula Check does this per ingredient.

2. 02Supplier documents

   Specifications and safety data sheets for each raw material, IFRA certificates for fragrances, and the impurity and purity data the assessor will read. Raw Portal collects them from suppliers.

3. 03Tests

   Stability and compatibility with the packaging, microbiological quality and, for products that can be contaminated in use, a preservation challenge test. Each one is run on the final formula.

4. 04Exposure and margin of safety

   How much of the product reaches the body each day, ingredient by ingredient (SED), set against each ingredient’s NOAEL: the margin of safety. How the margin is calculated.

5. 05Assessment and signature

   The assessor reads Part A, writes the reasoning and the conclusion, and signs Part B. Software can lay out Part A; the assessment is theirs. Where the line falls.

6. 06Keeping it up to date

   A new supplier, a changed formula or a new annex limit means the report is revised: Article 10(1)(c). Regulatory Watch names the products a change touches.

After the report: it goes into the product information file and the product is notified through CPNP in the EU or SCPN in Great Britain.

There is no fixed duration and no set fee. Both depend on how complete the file is when the assessor starts.

• Missing supplier documents: the most common delay, because they come from someone else.
• Missing tests: a test that has not been run cannot be replaced by reasoning.
• Ingredients with no published NOAEL: each one needs more of the assessor’s time.
• The assessor’s calendar, and how many variants the report has to cover.

The price follows the same things: the formula, the documents you already hold, the tests still missing and who signs. One provider’s published figure, and the seven factors, are in the cost guide.