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MoCRA deadlines for December
Facilities/product registrations, safety substantiation and an expectation of adverse reporting/record keeping system. Exemption exists for small business re. registrations/product listing.https://www.jdsupra.com/legalnews/preparing-for-the-december-2023-mocra-4613782/
jdsupra.com
Preparing for the December 2023 MoCRA Deadlines: What You Should Do Now | JD Supra
The Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”) contains several provisions that will go into effect on December 29, 2023. We have...
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13 Replies
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December 29, 2023
- MoCRA comes into effect.
- Products and facilities must be registered
- Safety substantiation must be available (toxicological risk assessment, cosmetic safety report)
- Responsible person has to establish a listing for existing cosmetic productsJune 29, 2024
- List of fragrance allergens must be on the ingredients list
- Cosmetics labels must include a domestic address, phone number, or electronic contact information of the responsible person
- If international, electronic information (website, email is required)
- The brand can be its own RP (Responsible Person)
- Foreign manufacturing companies must appoint a US agent
- Must be compliant with ISO / GMP guidelines
- Companies must have an adverse event reporting source on their website
- Responsible person must maintain records of all adverse events for 6 years and must report serious adverse events within 15 days
- Facility registration: update new information within 60 days
- Product listing: annual update is sufficient -
Wonder at the status then at the safety substantiation for the many alternative/natural ingredients and products. As this is noy CFSAN but a new FDA organization, folks migrating from CDER might want more than BS and an HRIPT.
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I’m relying on HRIPT 50-panel being acceptable for the foreseeable future. The genomic safety regimes show a lot of viability, not to mention lower cost, but I cannot predict what FDA will rule as valid. ON another note, looks like I may have a good post-retirement career as a beauty brand RP if I choose to do so. You and Mark are too young to think post-retirement for now.
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No kidding, think you could help a lot of folks in this. And I would love to hear the stories as you bring some of the clowns to Jesus on compliance
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I’m only a few years away from retirement. I have already been approached to be a RP for some of our clients so it sounds lucrative.
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Ingredient lists are going to get pretty long.. at .5-1% some of these fragrances have up to 13 allergens! ????
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The Essential Oils also have fragrance allergens which must be declared. In fact, some of my clients have seen far more reactions to EO’s than many fragrances.
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Oh absolutely agree. However I do notice essential oils may have 2-3 that will cross the .001% mark. Obviously some have more. But a lot of fragrances I checked, while less irritating, have more to list. I wonder ultimately how this will play out to the general consumer.
I’ve also been looking into UK brands and I see them approaching it two different ways..
Comapny 1: ingredient 1, ingredient 2, ingredient 3, ingredient 4, Parfum (fragrance), allergen 1, allergen 2, allergen 3
Company 2: ingredient 1, ingredient 2, ingredient 3, ingredient 4, essential oils*
*Some of the essential oils used contain some naturally occurring allergens: allergen 1, allergen 2, allergen 3
My assumption is company 1 is correct but I’ve seen a great deal going the route of #2. Some big brands too. Are they both correct? As long as you stipulate the allergens on the label is that being compliant? I thought I read it had to be part of the ingredients list itself, but I could be wrong.
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“Safety substantiation must be available (toxicological risk assessment, cosmetic safety report)”
Mark, are you speculating here or do you have some concrete info that the FDA will likely define Safety Substantiation in this manner? It would make sense, but MoCRA steers clear of requiring an EU-style Safety Assessment, although the FDA could require it.
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Most definitely speculating. The Guidance has been lacking for the most part.
That language was used in a slide during an FDA Seminar I attended (online). The FDA was very unclear regarding what will be required. When discussing the Fragrance Declaration the presenter submitted the EU Fragrance Declaration standards as their guidance for labeling Fragrance allergens.
Honestly, most of my clients are lines that do not manufacture themselves so we have been concentrating on registering their products and ensuring they have a RP assigned. We are also working on setting up adverse incident reporting procedures and updating the websites. Our clients generally do PET and patch testing already.
Many of the plants we work with are scrambling to meet the ISO/GMP standards. This is a huge undertaking and we have been referring them to other service providers.
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I have a feeling this is going to end up being another “Obamacare” website catastrophe and it will take some number of months to stabilize.
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I would have to agree. We have emailed some questions to the FDA regarding issues and the responses essentially were “we don’t know yet.”
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Think so Mark and in all regards. Suppose GMP’ by Dec. would translate minimally to the current guidance document. Safety subsantiation of ingredients and products will range from heavy data-based tomes of big guys to cut and paste sales brochures and blessings from credentialing guys to “we’ve sold it for years and no one has ever complained”. Micro will be a cop out minimally to USP 51..
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