Feel Free to ask our experts a question below:

Can product safety substantiation be provided in the format similar to EU Cosmetic PIF?

The FDA does not require a specific way for the information to come in. If the EU report contains the required information to demonstrate adequate substantiation of the safety of the product it is fine. It is your responsibility to make sure you have records to support this. The FDA have not stipulated what the report needs to look like.

Is a brand responsible for ensuring that contract manufacturers register their facilities?

Yes, you cannot do your product listing until they give you the FEI number. The RP is responsible for ensuring MoCRA compliance, one of which is facility registration, thus if you are the RP you are responsible for ensuring they register the facilities.

Who can be the responsible person? Must the responsible person be an individual person or the parent company?

It can either be an individual person or a position at a company - so long as someone is identifiable.

Do we need to be GMP certified or GMP compliant?

GMP compliant. The FDA does not certify facilities.

Will fragrances used in cosmetic products remain confidential aside from allergens or will the FDA be able to review the fragrance formulation?

The FDA can only request this information if a serious adverse event is linked to that specific ingredient.