Compliance with MoCRA: What cosmetic businesses need to know!
Compliance with MoCRA
Are you in compliance with MoCRA?
MoCRA isn’t just another set of regulations; it’s a game-changer with the FDA stepping up to the plate with enhanced authority over cosmetic products.
So, What does this mean for you?
In our latest blog post, we delve into MoCRA, decoding its impact on the cosmetic industry, and providing a roadmap for your next steps.
However, before we dive in, it’s crucial to grasp the fundamentals of cosmetics – What they are, where they are manufactured or processed, and who holds responsibility for them.
Check out our infographic below for insights.
Now that you have a solid understanding of what cosmetics entail, it’s worth noting that with the implementation of MoCRA you need to ensure,
Mandatory facility registration with the US FDA.
For every new cosmetic manufacturer or processor post MoCRA, facility registration with the US FDA should be completed within 60 days of their first activity as a mandatory requirement and renewed every two years.
What if you are a importer?
If you have an establishment manufacturing and processing cosmetic products in the US, you need mandatorily register your facility with US FDA.
Are there any exceptions?
Yes! There are a few exemptions. Check out our infographic below, to explore if you’re exempt from mandatory facility registration with the US FDA.
Note that the FDA possesses the authority to suspend facility registration in cases related to adverse health consequences, leading to prohibition on product distribution.
This emphasizes the paramount importance of ensuring your cosmetic products are safe for consumer usage.
Safety substantiation of cosmetic products: MoCRA says no to animal testing.
Are there any specifics tests that you need to perform?
The answer is “No!”
MoCRA avoids mandating specific tests for product safety. To ensure the safety of cosmetic ingredients and finished products, you have the flexibility to substantiate your safety data by using, but not limited to, the following sources:
MoCRA deadlines and next steps for Cosmetic manufacturers:
MoCRA has brought a new term into play: Responsible Person (RP) defined as the manufacturer, distributor or packer of cosmetic products in the US.
Who is a US Cosmetic RP?
A US Cosmetic RP is responsible for adhering to regulations, with their name and contact details to be included on the cosmetic label in accordance with the 609(a) of the FD&C Act or 4(a) of the Fair Packaging and Labelling Act.
“Here’s the twist – unlike the EU, a US Cosmetic RP doesn’t need to be a local resident of US!”
What your US responsible person is actually responsible for?
US Responsible Person is the maestro behind the scenes, juggling tasks that ensure your cosmetic products are safe. The US Cosmetic RP is accountable for:
The Cosmetics Direct is the new electronic submission portal developed by the FDA for “facility registrations” and “cosmetic product listings,” making the life of US Cosmetic RP’s much simpler.
On the hunt for the right Responsible Person for your beauty brigade? Look no further than RegTrac, Call us today!
Compliance with MoCRA requires more than just understanding; it demands a strategic partner with the expertise to guide and support. Seems challenging?
Fear not, RegTrac has got your back!
As we bid adieu to old norms, let’s remember: compliance is not just a rule; it’s a commitment to safe, innovative beauty.
