Within MoCRA a ‘facility’ is defined as ‘any establishment (including the establishment of an importer) that manufactures or processes cosmetic products distributed in the United States.’
To understand whether an establishment meets this definition of being a ‘facility’ there needs to be some clarification around what is meant by ‘manufacture’ and ‘process.’ The Food, Drug & Cosmetic Act 1938 defines the ‘manufacture of a cosmetic product’ as ‘the making of any cosmetic product by chemical, physical, biological or other procedures, including manipulation, sampling, testing or control procedures applied to product.’ This definition relates directly to the bulk formulation.
Therefore, the MoCRA definition includes an establishment which produces the bulk formulation and/or manipulates the bulk formulation (filling, for example).
If an establishment completes any of the following activities, they are not considered a ‘facility’ under MoCRA:
Further, MoCRA includes a specific list of places and establishments which are not considered as facilities and are therefore exempt the requirements under MoCRA:
For non-US based facilities, a facility registration is still required if the establishment meets the definition above. Non-Us based facilities will be treated as ‘foreign facilities’ by the FDA and will need to work with a domestic US agent to complete the facility registration. Non-US based facilities are also subject to FDA inspections and enforcement actions.
If an establishment meets the definition of ‘facility’ under MoCRA, they must complete a facility registration on the FDA Cosmetics Direct platform. Whilst the portal has not opened yet, the facility can prepare ready for when the portal opens by obtaining an FEI (FDA Establishment Identifier) number. This can be obtained from the FDA if the facility does not already have one, it will need to be included in the facility registration.
This link can be used to obtain or search for an FEI http://www.access data.fda.gov/scripts/FEI portal/index.cam?action=portal.login
Once the FDA Cosmetics Direct portal opens, the following will need to be included in the facility registration:
As well as obtaining an FEI before the FDA Cosmetics Portal opens, facilities should also obtain the category and Responsible Person for each brand the facility manufactures and/or processes for. Organising this information now will ensure the facility registration process within the portal is much easier to complete.
Once the facility registration has been successfully completed, the facility must renew the registration biennially (every 2 years).
