MoCRA safety substantiation: putting the product file together

MoCRA requires the responsible person to ensure adequate safety substantiation for a cosmetic and maintain records supporting it.¹ The supporting file should identify the marketed product and explain how the evidence supports its safety.

In the US framework, the responsible person is the manufacturer, packer, or distributor whose name appears on the label under the applicable provisions.² The scientific assessment and the organisation of its supporting file are related tasks, but filing a report does not complete the assessment.

MoCRA’s safety evidence standard

Section 608 defines adequate substantiation in terms of evidence sufficient, in the judgement of appropriately qualified experts, to support reasonable certainty that the product is safe under labelled and customary or usual use.¹

FDA does not prescribe one specific set of tests for every cosmetic or ingredient. Relevant existing information can contribute; the methods generating supporting data need to be scientifically robust.² The file should explain why the selected evidence is sufficient for this product, including its limitations.

Build the file around a product

For a moisturiser, begin with the formula version, intended use, directions, and relevant user group. Add the package and label versions. The reviewer needs to match that description to the commercial product.

Then index the supporting information:

This suggested index can be adapted to the product and the reviewer’s assessment. Give each document a reference and a short explanation of its role. Where a report concerns an earlier prototype, retain that sample identity and explain its relevance to the final formula.

Write down the reviewer’s reasoning

The assessment should identify the evidence considered, important assumptions, and any unresolved questions. Where a study used another material grade or sample, explain why it is relevant or what further information is needed.

Agree access to reports and explanations supplied by external laboratories or consultants. A reference to a document nobody on the responsible person’s team can retrieve leaves a practical gap.

Review changes after the assessment

If the assessed moisturiser moves to a different pump, describe the new package in a change record. Ask the qualified reviewer which parts of the earlier assessment need reconsideration and what further work is needed. Retain the rationale whether or not the reviewer requests new testing.

Retain the earlier assessment alongside the new review. The same process can address relevant changes to ingredients, specifications, formula, use, directions, or safety information. Assign any resulting work and keep it visible until resolved.

Select one marketed product and retrieve its current description, assessment, and cited reports. Repair missing references and ask the qualified reviewer to address any gaps in the assessment’s reasoning.

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