Hi Winston.
I suspect that every cosmetics company on the planet has heard of MoCRA and is trying to prepare for it. I know my company is. However, there is one massive issue currently especially around the facility registration and product listing pieces - FDA is yet to develop or release the databases that will need to be populated by industry and they have also not specified how the process will unfold especially around product listing. Far too many questions continue to exist especially since MoCRA implementation of these two key requirements is set to December 29, 2023. Considering that companies will also need to inform FDA of the actual manufacturing site for their products that they list, it is becoming very difficult to imagine how that can be met specifically for companies who use significant numbers of contract manufacturing sites or who are 100% contract manufactured.
Since the current requirement appears to be that you will need to include not only the product information on the product listing site but also include the establishment number for the manufacturer, and since the manufacturing site registration system is still not up and running (end of June already), and the fact that there is a docket currently open until tomorrow for comments on the FDA's current expectations with regard to establishment registration, product listing and labeling regulations and an open request to comment on much of this, and the fact that FDA is still yet to even propose a rule on how any of this gets done...I don't see how it is going to be done in time to meet the legislatively imposed deadline.
The other points (talc, safety substantiation, GMP) all have longer implementation periods but still the timing is rather tight at this point. FDA does have a guidance on GMP for cosmetics companies that basically pulls large pieces from ISO 22716 but legally they will need to enact whatever regulations that they choose as regulations since it is not legal as I understand it to require that people purchase regulations of an independent non-governmental organization. Since the ISO document is copywritten and includes several areas not traditionally recognized by FDA as GMP relevant it is going to be something that FDA will need to manage.
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Victor Mencarelli MS
Global Director Regulatory Affairs
New YorkNY
United States
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Original Message:
Sent: 29-Jun-2023 07:31
From: Winston Costa Pereira
Subject: MoCRA requirements.
I hope companies who deal with cosmetics are aware of the MoCRA requirements that will be in place later this year.this will include the facility and product registration, labelling changes, GMP requirements, safety substantiation and banning of asbestos in Talc products.
Winston Costa Pereira
Sent from my iPhone