Listen to the 3rd episode of our Assurance in Action 3-part podcast series on Cosmetic Regulations in the United States. Our latest podcast is dedicated to the requirements for cosmetic safety substantiation under MoCRA. To learn more about the requirements, stream our podcast now.
Speakers:
Follow us on- Intertek's Assurance In Action || Twitter || LinkedIn.
Listen to the 3rd episode of our Assurance in Action 3-part podcast series on Cosmetic Regulations in the United States. Our latest podcast is dedicated to the requirements for cosmetic safety substantiation under MoCRA. To learn more about the requirements, stream our podcast now.
Speakers:
Follow us on- Intertek's Assurance In Action || Twitter || LinkedIn.
00:14 --> 00:30
Speaker 1
Hello, everyone! Welcome to Intertek’s Assurance in Action podcast.
My name is Alexandra Minich and I am a Toxicologist with Intertek’s Home & Personal Care group. I will be your host for this episode.
I am joined here by Heidi Reamer, Manager of Toxicology in our group.
00:30 --> 00:32
Speaker 2
Hey Alexandra! Thanks for having me!
00:32 --> 00:47
Speaker 1
Thank you for joining!
So, Heidi, on your last podcast you recapped the “Modernization of Cosmetics Regulation Act,” which we call “MoCRA.”
Today, I’d like to take a deeper dive into the safety substantiation requirement of MoCRA.
00:47 --> 00:48
Speaker 2
Sounds great!
00:48 --> 00:53
Speaker 1
To start, can you tell us what this requirement is?
00:53 --> 01:06
Speaker 2
Sure, the requirement is that the Responsible Person must ensure that the safety of their cosmetics product is adequately substantiated, and must maintain record of that substantiation.
01:06 --> 01:15
Speaker 1
Ok, that sounds simple, but I bet there’s a lot to unpack. Let’s get into the details.
For one, who is the Responsible Person?
01:15 --> 01:26
Speaker 2
The Responsible Person is the manufacturer, packer, or distributor of a cosmetics product whose name appears on the product label. In most cases, this will be the brand.
01:26 --> 01:35
Speaker 1
Right, thanks for clarifying.
So, does the regulation give any guidance on what is meant by “safety” or “safe”?
01:35 --> 01:57
Speaker 2
Yes, the regulation does clarify that “safe” means that the cosmetics product is not injurious to users under the conditions of use listed on the product label or under conditions of use that are customary for that product type.
Oh, and I should note that this applies to the cosmetics product as a whole, as well as the individual ingredients within that product.
01:57 --> 02:07
Speaker 1
Ok, so you mentioned that the Responsible Person has to “adequately substantiate” the safety of their cosmetics product. Can you tell me more about that?
02:07 --> 02:35
Speaker 2
Definitely!
We can start with the definition from the regulation: “Adequate safety substantiation” 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.”
02:35 --> 02:44
Speaker 1
Hmm, that isn’t very specific. Has the FDA clarified what information and which tests are required to confirm a product is safe?
02:44 --> 02:48
Speaker 2
No, the FDA has not specified this.
02:48 --> 02:56
Speaker 1
So, how should a Responsible Person go about ensuring the safety of their product? How do they know what to do?
02:56 --> 03:16
Speaker 2
This is a great question! Well, the short answer is that it will vary by product.
But a good place for a brand to start is with their safety and toxicology experts, who can develop a thorough safety substantiation plan.
Many brands don’t have those specialties in-house, and that’s ok! That just means it’s time to bring in outside help.
03:16 --> 03:25
Speaker 1
Our team has been helping brands with cosmetics safety for years, and I’m assuming that Intertek can help here, with MoCRA safety substantiation as well?
03:25 --> 03:30
Speaker 2
Definitely, that’s where we come in! It’s a key area of expertise for our group.
03:30 --> 03:34
Speaker 1
That’s great! So, can you walk me through our process? Maybe provide some examples?
03:34 --> 04:09
Speaker 2
Absolutely.
Our first step is to get a better understanding of the product. We’ll start by asking questions like:
• What type of product is it?
- For example, shampoo, eyeliner, nail polish, etc.
• Who uses the product?
- Is it only for adults, or is it used on babies and kids too?
• What are the product’s conditions of use?
- For example, is it applied to the whole face or maybe just around the eyes? Is it used on the hair, or maybe the whole body?
- Once it is applied, is it rinsed off like a shampoo or left on the skin like a lotion?
04:09 --> 04:15
Speaker 1
Alright, so once we get a sense of the product and how it’s used, where do we go from there?
04:15 --> 04:45
Speaker 2
Typically, we perform a Cosmetic Safety Assessment.
This assessment includes a toxicological review of each ingredient to confirm that they are safe under the expected conditions of use for that product. We will also conclude on the safety of the product as a whole. The assessment is delivered as a report, and it can be used towards the safety substantiation requirement of MoCRA.
Oh, and I should mention our report also captures any information or product testing that supports the product’s safety.
04:45 --> 04:51
Speaker 1
Ah, ok, what are some examples of this additional information that might be included?
04:51 --> 05:12
Speaker 2
Well, raw material suppliers may have safety information on their individual ingredients. For example, if they conducted eye or skin irritation tests with their ingredient, we would consider the results in our Cosmetic Safety Assessment.
Also, if the brand has cosmetovigilance data on the product or products that are similar to the product in question, that will be considered too.
05:12 --> 05:23
Speaker 1
I see. And regarding testing, some places like the EU have banned animal testing on cosmetic raw materials and finished products. Is that the case in the US as well?
05:23 --> 05:41
Speaker 2
In the MoCRA regulation, Congress indicates that “animal testing should not be used for the purposes of safety testing on cosmetic products and should be phased out with the exception of appropriate allowances.”
So, the use of animal testing is discouraged in the US, but it is not banned outright.
05:41 --> 05:58
Speaker 1
Interesting, thanks for clarifying.
While we are on the subject of the EU, I know that certain substances are banned or restricted according to the Annexes of EU Regulation No. 1223/2009.
Did MoCRA establish a similar list of banned and/or restricted ingredients?
05:58 --> 06:15
Speaker 2
No. No list of banned or restricted ingredients was created under MoCRA.
However, bans on certain substances in cosmetics, like chloroform and methylene chloride, are already in Title 21 of the U.S. Code of Federal Regulations (or CFR), and these bans still apply.
06:15 --> 06:23
Speaker 1
Got it.
You said that product testing results are included in our Cosmetic Safety Assessment. Can you tell me which tests you mean?
06:23 --> 07:00
Speaker 2
Yes. So, we recommend tests based on the composition of the product.
For example, microbes like bacteria grow in water. If the formulation contains water, we will recommend microbiological testing to verify that the product is not contaminated.
And if the product contains a preservative to control microbes, it should be tested with a preservative effectiveness test to verify the preservative works as expected.
Another common test is stability, which looks at how the product does under different storage conditions over months to years.
All that is considered in the Cosmetic Safety Assessment.
07:00 --> 07:04
Speaker 1
And what about clinical testing? Is that required?
07:04 --> 07:44
Speaker 2
Certain clinical tests may be recommended. For example, to confirm the skin irritation and sensitization potential of a product, we may recommend Human Repeat Insult Patch Testing.
Depending on where the product is applied, additional testing might be recommended. For example, an eye shadow or eyeliner could be tested under ophthalmological review to confirm that the product is ok to use around the eyes.
And the user of the product should also be considered. For instance, we may run an in-use test under paediatric review for products intended for babies.
Really, it will depend on the product formulation, who uses the product, and where on the body it is used.
07:44 --> 08:01
Speaker 1
You mentioned the Human Repeat Insult Patch Test, which we know as “HRIPT”, a pretty common test in the cosmetic industry.
Say a company completes HRIPTs on all their products and gets desirable results, would that cover the safety substantiation requirement?
08:01 --> 08:12
Speaker 2
No. An HRIPT is a great start to substantiate safety, but it does not capture all toxicological endpoints needed to determine if the product’s use is going to be safe.
08:12 --> 08:20
Speaker 1
Interesting, okay. Thanks for clarifying, Heidi!
You mentioned record keeping earlier. Can you tell me more about that?
08:20 --> 08:36
Speaker 2
Yes, the Responsible Person must keep a record of the safety substantiation for their cosmetics product, and the importance of this requirement cannot be overstated. Without evidence of adequate safety substantiation, the FDA considers a cosmetics product to be “adulterated.”
08:36 --> 08:41
Speaker 1
Oh, interesting. What are the ramifications of having an adulterated product?
08:41 --> 09:03
Speaker 2
Well, the FDA has mandatory recall authority. This means that the FDA can require a company to recall an adulterated product if they suspect the product might cause harm.
As part of a recall, the FDA will issue a press release to the public that includes the name of the product. They may also post an image of the cosmetic on their website. It’s not a great look for a brand!
09:03 --> 09:08
Speaker 1
Ok, so it is really important to have records showing that a product is safe.
09:08 --> 09:18
Speaker 2
Absolutely. In addition to preventing recalls and bad publicity, safety substantiation is important for brands that want to provide safe products that their consumers can trust.
09:18 --> 09:25
Speaker 1
And what counts as “a record”? Is a Safety Data Sheet a sufficient record of safety substantiation?
09:25 --> 09:46
Speaker 2
No, an SDS is not an adequate safety assessment, as it does not include the specific application of the product as it will be used.
The Responsible Person should have the full file of information that supports the product’s safety. For example, the Cosmetics Safety Assessment, testing reports, raw material documentation and SDS.
09:46 --> 09:55
Speaker 1
Got it.
In MoCRA, there are certain exemptions for small businesses. Are small businesses exempt from safety substantiation?
09:55 --> 10:12
Speaker 2
Definitely not!
The small business exemption applies only to certain sections of the regulation. The exemption does NOT apply here.
All brands that sell cosmetics products in the US, regardless of their size, must ensure that their products are safe and must document that safety substantiation.
10:12 --> 10:24
Speaker 1
Ok.
As you mentioned earlier, brands might not have the capability to substantiate safety themselves. What would you recommend to those brands so that they can comply with the regulation?
10:24 --> 10:47
Speaker 2
Yes, it’s often the case that brands don't have the resources to fully support safety substantiation - it's complex, technical, and can be a lot to manage. But that's why we are here!
We have a team of safety and regulatory experts to help brands with all aspects of MoCRA, including safety substantiation. It's what we do every day, and we enjoy helping our clients through the compliance process.
10:47 --> 10:55
Speaker 1
That’s really great to know.
Heidi, you gave us a lot of info, and I want to thank you for walking us through the safety substantiation requirement of MoCRA today.
10:55 -->10:59
Speaker 2
Of course, it’s my pleasure. Thank you, Alexandra!