Right. Those exemptions are to sections 606 & 607. Not 608 (safety)
New US FDA regulations for Bath & Body
- Thread starter paradisi
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As to shaving soap, I don't make it but assume it is still regulated as a cosmetic so the new rules would apply.
https://www.soapmakingforum.com/thr...smetic-according-to-the-fda-in-the-u-s.74856/
https://www.soapmakingforum.com/thr...smetic-according-to-the-fda-in-the-u-s.74856/
I have a feeling identifying fragrance allergens is going to be fun especially considering FO companies recently went through the IFRA updates. We have lost quite a few companies in recent years. :-/
I gotta get a paper copy of the cosmetics section or find a more readable source. My phone just hates the bill's site right now.
I gotta get a paper copy of the cosmetics section or find a more readable source. My phone just hates the bill's site right now.
You can download the text from the bill site, scroll down a bit and the link to the text pdf is listed. I just did that to save my eyes! Reading it on the laptop.
I'm thinking the allergens thing may be not so bad; I've noticed recently that lots of SDS now list ingredients in ppm. That will be simple enough to translate into ppm in products as it's just % fragrance used x ppm (or %) of the specific ingredients .
And at the low levels used in many cosmetics, often 0.5% to 1%, that may mean not so many additions on labels.
So here's what the bill says about safety:
(my phone has trouble with the pretty symbols)
"DEFINITIONS.�For purposes of this section:
��(1) ADEQUATE SUBSTANTIATION OF SAFETY.�
The term �adequate
substantiation of safety� means tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic
product is safe."
.. which sounds to me more like lots of documentation, than having assessors .
As we're probably all keeping all that stuff (ingredient SDS's, IFRA sheets, mfr info sheets, CIR-Safety reports, etc) along with good record keeping, perhaps the process can be made not overly burdensome or killingly expensive.
I'll be contacting the HMSG , for sure.
(my phone has trouble with the pretty symbols)
"DEFINITIONS.�For purposes of this section:
��(1) ADEQUATE SUBSTANTIATION OF SAFETY.�
The term �adequate
substantiation of safety� means tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic
product is safe."
.. which sounds to me more like lots of documentation, than having assessors .
As we're probably all keeping all that stuff (ingredient SDS's, IFRA sheets, mfr info sheets, CIR-Safety reports, etc) along with good record keeping, perhaps the process can be made not overly burdensome or killingly expensive.
I'll be contacting the HMSG , for sure.
Thanks, downloaded it, and it's way easier to peruse.
The thing about labeling allergens is that everything can be an allergen, even water. Is it possible to just say "allergens possible" as part of the label? I take it this means that we can't use "fragrance" as the inci anymore and have to give detailed description of whats in the fragrance? Paradisi, I'm so glad you're here to understand these lol. Because it's like reading an alien language to me.
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We're all on a learning curve here!The allergens addition to labels will be fragrance allergens.
And the FDA will promulgate a list of what molecules will need reporting at what level.
So "all" we'll have to do, lol, is to find which of those would be present at a reportable level in what product. Vendors will provide us that info ... many stateside already do EU allergen sheets. I'm guessing they will be very similar.
In practice, that will mean something like: "this fragrance has these reportable compounds in it at Y levels; my product uses the fragrance at (whatever safe level) x%, so there's x% times Y much of those compounds in the product; of those, this or that (or possibly none) is at a reportable level and will go on the label.
Other types of allergens aren't mentioned in this labeling ruling. I think most of us are careful to point out the common allergens (like dairy or nut oils, say) as well as full ingredient decks, anyway; this will just add those 'linalool, limonene' things where appropriate.
Yes, very well stated!
Michelle0803
Well-Known Member
I found this 10 page summary of the changes that I personally found helpful. However I will be reviewing again to see if I can find answers to my own questions.
https://www.afslaw.com/sites/defaul...ation_of_Cosmetics_Regulation_Act_of_2022.pdf
https://www.afslaw.com/sites/defaul...ation_of_Cosmetics_Regulation_Act_of_2022.pdf
A good point in the pdf Michelle links to above is the effective date for the safety stuff appears to be the end of 2023.
There's no timeframe listed in section 608, but at the end of the sections, where the text edits are listed, there's a line saying that the edited sections take effect a year after the law is passed.
So that gives 8 months to get safety substantiated.
It's a bit concerning to me that (AFAIK) none of the big suppliers, nor HMSG, nor cosmetics bloggers, have said anything about how that will be established. Outside of some sneering on chemistry of cosmetics forums about how it will get rid of Etsy sellers
.
My current guess is that they've forgotten small sellers exist or misread the small business exemption part.
Though perhaps we can just take the literal wording of the section to mean gathering documentation. The percentage of US cosmetics sales that comes from tiny vendors is after all .. tiny. So probably not of huge immediate concern to regulators.
Will be interesting to see how it develops.
There's no timeframe listed in section 608, but at the end of the sections, where the text edits are listed, there's a line saying that the edited sections take effect a year after the law is passed.
So that gives 8 months to get safety substantiated.
It's a bit concerning to me that (AFAIK) none of the big suppliers, nor HMSG, nor cosmetics bloggers, have said anything about how that will be established. Outside of some sneering on chemistry of cosmetics forums about how it will get rid of Etsy sellers
.My current guess is that they've forgotten small sellers exist or misread the small business exemption part.
Though perhaps we can just take the literal wording of the section to mean gathering documentation. The percentage of US cosmetics sales that comes from tiny vendors is after all .. tiny. So probably not of huge immediate concern to regulators.
Will be interesting to see how it develops.
Marie Gale has a good overview here:
https://www.mariegale.com/cosmetic-regulation-update-2022/
and says both that safety is likely to mean documentation, and that the preemption clause *may* ease up things on makers in states like Florida, as states won't be allowed to make more stringent requirements than federal ones.
https://www.mariegale.com/cosmetic-regulation-update-2022/
and says both that safety is likely to mean documentation, and that the preemption clause *may* ease up things on makers in states like Florida, as states won't be allowed to make more stringent requirements than federal ones.
I'm following along because I've been thinking about the pros and cons of selling soap and B&B for months now. I found a webpage about MoCRA on the Modern Soapmaking site. It contains a bit of promotion for the course they offer for soap makers, but is easy to read.
what a pita. Well, that's better than the inspection of my kitchen every six months or something stupid like that.
The allergens addition to labels will be fragrance allergens.
And the FDA will promulgate a list of what molecules will need reporting at what level.
So "all" we'll have to do, lol, is to find which of those would be present at a reportable level in what product. Vendors will provide us that info ... many stateside already do EU allergen sheets. I'm guessing they will be very similar.
In practice, that will mean something like: "this fragrance has these reportable compounds in it at Y levels; my product uses the fragrance at (whatever safe level) x%, so there's x% times Y much of those compounds in the product; of those, this or that (or possibly none) is at a reportable level and will go on the label.
Other types of allergens aren't mentioned in this labeling ruling. I think most of us are careful to point out the common allergens (like dairy or nut oils, say) as well as full ingredient decks, anyway; this will just add those 'linalool, limonene' things where appropriate.
This is another overview, detailed but easy to read.
https://www.clarkhill.com/news-even...ization-of-cosmetics-regulations-act-of-2022/
https://www.clarkhill.com/news-even...ization-of-cosmetics-regulations-act-of-2022/
I just emailed the guild. Hopefully they have some answers. Reading whats been shared, the inspection thing and the like does seem to apply to all of those making in our kitchens.
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Another part of all this that really gripes me is that with every bit of new information some regulatory agency deems important to be cited on labels, the print becomes smaller and smaller to fit it all in. I can't read the verbage on most labels anymore without a magnifying glass, so it all becomes pointless.
Thank you, @Mobjack Bay for that link; that is a great summary by Kenna on Modern Soapmaking. Based on the following excerpts from her article (some of which I have consolidated to reduce the number of words) most SMF members will probably qualify for the "small business" exemptions (and if you don't, you should be making enough $$ to absorb the compliance costs).
- Most small businesses will be exempt from the most drastic changes. MoCRA includes all of the exemptions that industry advocates have fought for over the years, including longer timelines for implementation, special consideration for budgets and size, and being entirely exempt from more demanding requirements.
- Product type classification (soap or cosmetic) has not been modified or updated. If you make a true soap from saponified oils without making any claims about the product beyond cleansing, the existing FDA regulations do not apply to your product, nor does MoCRA. If you make any cosmetic or drug claims, you will still be subject to the rules related to cosmetics and drugs.
- Small businesses (defined as average gross annual sales less than $1M for the previous 3-year period) are fully exempt from facility registration, product listing submission, and mandatory GMP, and will only be subject to a three-year period of maintaining adverse event records (instead of six years), as long as they do not make any of the following:
- cosmetics that come in contact with mucus membranes of the eye
- cosmetics that are injected
- cosmetics that are intended for internal use
- cosmetics that intend to alter the appearance for more than 24 hours
- Small businesses are subject to requirements related to labeling, site inspection, safety substantiation, recalls, and record-keeping (with the shorter time frame re: adverse events).
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The good manufacturing process thing is the only part that would include inspections and that's section 606, which does not apply to small businesses . We're not facilities under that. No registration , no GMP enforcement .
In fact a text search for the word inspection only comes up with records inspection if a product is found to be adulterated , or upon causing a serious adverse health event (i.e., if someone dies or is hospitalized or the like, from your product). Which seems right & proper, and also vanishingly rare.
In fact a text search for the word inspection only comes up with records inspection if a product is found to be adulterated , or upon causing a serious adverse health event (i.e., if someone dies or is hospitalized or the like, from your product). Which seems right & proper, and also vanishingly rare.
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