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MoCRA – Systems You Must Have In Place By December 29, 2023
MoCRA (Modernization Of Cosmetics Regulations Act Of 2022) goes into effect December 29, 2023. Not all of MoCRA’s requirements will go into effect immediately on that date and will be phased-in over the next 3 years. Here are the systems you must have in place by 12/29/23 in addition to registering your products and/or facility:
Mandatory Product Registration (by December 29, 2023).
The FDA will be publishing the Mandatory Product Registration Portal in October, 2023. All cosmetic products must be registered in the portal by December 29, 2023. The only exemption from Product Registration are small companies with revenues of less than $1.0 million for the previous 3 years.
Product Safety Substantiation Dossier (by December 29, 2023).
All companies, regardless of size, will be required to maintain Safety Substantiation Dossiers on all of their cosmetic products. The Safety Substantiation Dossier should include Preservative Challenge Testing, 48 Hour or HRIPT (Human Repeat Insult) Patch Testing and Ingredient Toxicology Safety Assessment. For more detailed information read: https://lnkd.in/epsVZGdS
Adverse Event & Serious Adverse Event Reporting (by December 29, 2023)
All companies, regardless of size, will be required to file Adverse Event and Serious Adverse Event reports with the FDA. The FDA has modified product Labeling Rules to allow companies to list a website and e-mail for consumers to contact the Responsible Person (ie: The Brand) to report AEs and SAEs. All Adverse Events must be reported to the FDA within 15 days of receipt of the AE/SAE notification from a consumer. The FDA is establishing an Adverse Event reporting portal to electronically files AE/SAE reports. For more detailed information read: https://lnkd.in/eaYidM2S
Listing Of Fragrance Allergens On Product Labels (by December 29, 2024)
All companies, regardless of size, will be required to list Fragrance Allergens on their product labels whether you are using a manufactured fragrance or essential oil blends. For more detailed information read: https://lnkd.in/ea5VYCGq
If you need assistance with Safety Substantiation or any other aspect of MoCRA compliance, contact Bloom Cosmetic Test Lab ( https://lnkd.in/eV6pp5sJ ) and we can guide you through MoCRA Compliance with our MoCRA Compliance Officer service.
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Mark Broussard on LinkedIn: #mocra #clean #cleanbeauty
Guidance For Indie Beauty Brands MoCRA: What Exactly Is Safety Substantiation According To The FDA? While MoCRA provides a small company exemption from FDA Pr…
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14 Replies
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Do you think MoCRA will follow the EU with their 82 Mandatory allergens or the old 26 allergens used by a few other countries or publish a list of their own?
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More will be known about that towards the end of 2023 when the FDA will present their reportable list of fragrance allergens. Once that list is published, there will be a 6 month public comment period and the list will be finalized in mid-2024 and the labeling requirement will go into effect at the end of 2024.
My guess: It will be the 26 EU fragrance allergens, plus some from the additional 56 going into effect in the EU in September 2023, but not all 82 EU fragrance allergens.
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Thanks for the info
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I’m watching this with GREAT interest.
The manufacturing company I founded and managed (I was the Master Formulator) for 20 years manufactured for brands globally. A lot of these brands we manufactured for were based in the EU, therefore we adopted the EU standards in all manufacturing and all compliance.
BTW, our factories/businesses were located in Viet Nam and Malaysia.
Manufacturing under the EU standards made it very easy for us to manufacture and export to US brands from our Viet Nam and Malaysia facilities. From our perspective of the EU standards, the requirements in the US were almost non-existent.
Therefore, I will be watching very closely how the MoCRA rolls out. Having setup from scratch, and run a manufacturing facility for 20 years under EU guidelines, I see this as a huge challenge for many US based manufacturers.
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@MarkBroussard Question regarding the safety portion. You claim all companies, regardless of size will have to provide 48 Hour patch testing, ingredient toxicology safety assessment.. which makes sense for generally all products.
But you also state they must perform Preservative Challenge Testing on all products, what about anhydrous products? Wouldn’t these products fail a preservative challenge since there is no preservative? In example a body butter which contains only shea butter, mango butter, some carrier oils (argan, jojoba, etc), and then essential oil or fragrance. Or even hair oils or beard oils, which just include carrier oils and a scent. Sort of confused here on that aspect, everything else makes general sense to me.
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There are no specifics at this time tho’ HRIPT is reasonable - but may be be minimal. If micro is required, it’ll probably be satisfied with a risk assessment that includes challenge as appropriate.
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<div>Thank you for your input Phil! Any idea when can we expect the specifics for all of this? Seems crazy they expect these to be in effect in December and still haven’t released the definitive specifics for their requirements?</div>
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Mark’s post was spot on for dates of compliance. Agree, timing looks tough but the Agency will likely take the position that safety has always been a requirement and this merely asks that it be documented. To your concern for anhydrous, generate a justifying risk assessment
Establish your “responsible person”.
Begin your own adverse reporting system.
Work in good faith. Comply to the letter of the law - no more no less. Ask questions here.
Be aware - this is a new group at FDA. We don’t know if it will include the CFSAN folks who had cosmetics before but the CFSAN guys I know do not expect to move . In any case, the new bunch is scrambling to build an org. and meet their own target dates.
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Safety Substantiation: The FDA clearly states that neither MoCRA nor the FDA require specific tests to establish Safety Substantiation so there will not be a specific set of tests required by FDA.
The FDA does talk about Micro and Ingredient Toxicology from published data in its discussion of Safety Substantiation with no mention of Patch Testing. But, one can reasonably surmise that these three components are the essential elements of establishing safety. The granular specifics of Safety Substantiation are going to be established by the retailers such as Amazon, Ulta, Sephora etc. who are currently requiring PCT and HRIPT. For ingredient toxicology a full CPSR is not required in the US and EU firms are offering scaled-down ingredient tox reports for the US market.
Anhydrous Products: There are challenge tests for anydrous products available from various labs. Probably worth the $500 or so to run one to build your Safety Substantiation Dossier.
If you are DTC and not trying to sell through Amazon et al, then you best approach is PCT, HRIPT and Ingredient Tox Report.
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Mark can you share the FDA source comments mentioned?
Disagree with running some test on whatever “anhydrous” product - unless you know what the results should be, have reason to beleive you’ll pass and plan to do it ongoing. USP 51 is weak enough in validation - many anhydrous tests are pretty flakey.
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Here’s the language from the FDA MoCRA Draft Guidance For Industry
“Safety Substantiation: Companies and individuals who manufacture or market cosmetics have a responsibility to ensure the safety of their products. Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients.”
“A Responsible Person (ie: the Brand) is required to ensure and maintain records supporting adequate safety substantiation of their cosmetic products. Manufacturers (Brands) can use relevant safety data that is already available to support the safety of their products. Animal testing is not a requirement for marketing a cosmetic product. It’s important, however, that all data used to support the safety are derived from scientifically robust methods.”
Yeah, I have never had an anhydrous product run through PCT, but have seen it offered by a couple of labs. Interested in hearing your thoughts/advice on micro testing on anhydrous products.
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Thanks Mark.
The anhydrous tests I’ve seen are tests for the sake of a test. They strain to offer any sense of reality. Failure may mean little to nothing re. actual risk but more apt to fail than not - sure would screw up ones safety assessment. Jumping in with a product already on the market could be a disaster - failure a time bomb waiting for some regulator or law suit to discover.
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Thanks for the info, I appreciate it.
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I’ll counter here that MoCRA regulations are not a big deal and are more significant for what they omit than what they contain. I’ve worked in FDA registered drug producing establishments nearly my entire 40-year career and have compiled export docs to Asia, EU, China, LatAm also during that time. There is nothing novel about MoCRA and in fact facilities that are solely Chapter V producers are entirely exempt from it. What is significant is what they left out. No harmonization of the ingredient “denials” in all 50 states - a major flaw - and no language anywhere for label review of claims or other criteria. Posting your label into the Product Listing portal is only “optional” not mandatory, not that it would matter as there is NO FDA LABEL REVIEW mechanism or acceptance criteria. The product label chicanery and greenwashing (i.e. “natural vegetable glycerin”) will continue in the USA whereas EU, China and even Canada took steps to counter this. As a certain orange-hair narcissist freak of an ex-president would have tweeted: SAD
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