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Really, really stupid company
I’m writing AGAIN about this styooopid company, ‘Carina Organics’. It is their PURE & NATURAL DAILY LIGHT CONDITIONER
They had a recall in 2009 by Health Canada for contamination of their PURE & NATURAL DAILY LIGHT CONDITIONER. AND, it’s no surprise, since they do NOT use any sort of preservative. AND they have NOT bothered to correct their formula.
Here’s the ingredient list from 2009 when the recall happened.
July 2009:
Aqua, Cocos nucifera (coconut) oil, Pinus divaricata (pine) extract, Pinus banksiana (pine) extract, Chamomilla recutita (matricaria) flower extract, Blechnum spicant (fern) leaf extract, Urtica dioca (nettle) leaf extract, Taraxacum officinale (dandelion) leaf extract, Trifolium pretense (clover) flower extract, Acetic Acid, Olea europaea (olive) fruit oil, Curcurbita pepo (pumpkin) seed oil, Beeswax, Lathyrus odoratus (sweet pea) flower extract.
Here’s their CURRENT ingredient list, showing they don’t give a shit about safety. ARGH!
Filtered Aqua, Cocos nucifera (coconut) oil, Cetyl Alcohol (fatty alcohol from Coconut), Olea europaea (olive) fruit oil, Linum usitatissimum (linseed) oil, Cucurbita pepo (pumpkin) seed oil, Helianthus annuus (sunflower) seed oil, Persea gratissima (avocado) oil, Pinus elliottii (pine) extract, Pinus banksiana (pine) extract, Matricaria chamomilla (chamomile) flower extract, Urtica dioca (nettle) leaf extract, Taraxacum officinale (dandelion) leaf extract, Trifolium pratense (clover) flower extract, Citrus tangerina (tangerine) oil, Pyrus malus (green apple) extract, Ananas sativus (pineapple) extract, Magnesium Chloride (Magnesium Oil), Cyamopsis tetragonoloba (guar/cluster bean) gum.
This is the LOI for the BABY LOTION.
Notice that the ingredients are very similar to their crappy conditioner, including NO PRESERVATIVE(s). Again, this is to be smeared on a BABY!!!
Ingredients: Filtered Aqua, Cocos nucifera (coconut) oil, Cetyl Alcohol (fatty alcohol from Coconut), Olea europaea (olive) fruit oil, Cucurbita pepo (pumpkin) seed oil, Pinus elliottii (pine) extract, Pinus banksiana (pine) extract, Matricaria chamomilla (chamomile) flower extract, Urtica dioca (nettle) leaf extract, Taraxacum officinale (dandelion) leaf extract, Trifolium pratense (clover) flower extract, Acetic Acid (Apple Cider Vinegar), Magnesium Chloride (Magnesium Oil), Cyamopsis tetragonoloba (guar/cluster bean) gum.
I wrote ‘Carina Organics’ & asked what preservative they use in this baby lotion. Here is their response, please be sure you are SITTING DOWN, NOT EATING OR DRINKING ANYTHING when you read their response. You have been warned ????:
Thank you for reaching out! Happy to hear you enjoy our baby lotion. Our products have a 3 year shelf life due to our unique use of pine extract. This ingredient (made in-house with the sap from local pine trees) offers both natural antimicrobial and antibacterial properties. I hope this helps. Should you have any other questions, please let us know!
Please write any comments you wish, since I will be posting this atrocity in a ‘Zero Waste’ feces book group I belong to. Sadly, MANY of the members of the group are the type who think natural & organic is the best, and I figure I might as well make myself UNpopular by giving them this excellent example of garbage being sold for use on BABIES(!!!) plus the recalled hair conditioner info.
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52 Replies
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Regarding the baby lotion….I am always amazed…at what a robust emulsifier cetyl alcohol is…stand alone. ???? ???? Don’t even start….with all the potential allergens!
Apparently their MODUS OPERANDI is: Don’t list anything without a pretty name. 🙂
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This is super dangerous and unfortunately this trend isn’t going anywhere. Its gotten so bad that based on my knowledge of natural products, that I refuse to buy things if they are unpreserved or sold in specific stores.
The sad thing is this won’t end well. I am 100% sure that they have received complaints from customers or noticed stability issues in their products, however due to a lack of knowledge think its part of the course. That growth? Its the pine tree ????
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That growth? Its the pine tree
LOL
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Must agree….this is amazingly stupid.
But my question is. If they are producing under GMP Certificated conditions, why aren’t these formulations and supporting Challenge Tests not picked up during GMP audits? In our case, it certainly would be.
My only assumption, therefore, is that this company not producing under GMP Certificated conditions.
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Why did you conclude they are GMP? Is that mandatory in Canada?
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We have exported to many countries and most customers are requesting our GMP data in order to conform with local regulations. My assumption is that it is mandatory.
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Right - this is garbage waiting for a bug to drop in. Suppose it’s feasible it might have met the nominal criteria of 51 but no GMP’s will save that mess and in-use contamination is certain.
Granted this is obvious but a lot of the Ecocert and other “clean” systems I’ve seen here are not much better.
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What “GMP data” are you sharing?
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When you ask “What “GMP data” are you sharing?” then it’s everything.
First, ee need to notify the product before it goes onto the market with National Pharmaceutical Regulatory Agency (NPRA). They of course will check the ingredients list and preservative regime.
Next, we have “surprise visits” by the local office of NPRA. Here it’s a case of a phone call saying they are outside and want access. These are short, very focused visits. And all of our records and Batch Manufacturing Records (BMRs) must be available. We can never know what they will focus on.
And finally, we have formal inspections every two (2) years. Here a team from the NPRA Head Office will spend one or two days going through everything.
Across all of these compliance checks, the issues identified with this “stupid company” would be identified.
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@Margaret Next time your kids (assuming you have kids) are sick, let them cough into the product (to ensure contamination with the right bug), and sue the company for causing the illness 😉 . You’re not only getting tuition fees for your kids sorted out but also safe other kids from really becoming sick. ????
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Nope. I did not want to add to the poopulation. We have a cat.
I will be giving a letter to the manager of the store that stocks this crap, and I’ll include the Health Canada recalls & point out to the manager that this moronic company is STILL, NOT using a REAL preservative. The company’s pine sap they use to preserve this sorry excuse of a conditioner (and also the baby lotion) is NOT “cutting it”.
I had already pointed this fact out to the store manager a few years ago, and she said something along the lines of “we haven’t had any complaints”.
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Let’s hope the Pine Extract is adulterated with parabens or other real preservatives like some of these other natural preservatives. ????
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Pretty safe to assume. 🙂 (Or…there were plenty of extracts to hide the real preservative in.)
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What is “everything” GMP data? Finished product and raw material testing? monitoring data? water testing? batch sheets? yield? training records?
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In response to your question “What is “everything” GMP data? Finished product and raw material
testing? monitoring data? water testing? batch sheets? yield? training
records?”The answer is yes, yes, yes, yes, yes, yes, and yes to each.
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Thanks. Do they ever ask questions re. the data?
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And in response to your question “Do they ever ask questions re. the data?“
Yes, absolutely. During the audit, there will be numerous verbal questions. And these will be followed up with more detailed written questions.
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Wow, This is sickk on all levels, i can imagine your reaction when they sent in their reply????. Oh. 3 years Shelf life because it contains Pine Extract . What a Joke!!!
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Their claim of this crappy formula lasting 3 years almost made my hair go frizzy.
I am nervous about using a simple 2 year old lotion I made in which I use Germall preservative, never mind some crap these people make with pine sap as a preservative (AND it’s loaded with plant extracts too, apparently), for christ’s sake.
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They finally admitted they use a surfactant in their shampoos!!!! Capryl Glucoside, and that is not the correct inci either. It’s capryl caprylyl glucoside and the CAS number is also as Decyl glucoside so they could be using that. They list it as from coconut oil but generally it’s from palm and-or coconut. I got the exact response when I asked about preservative, and also I wanted to know how they were able to produce a ph balanced shampoo using potassium cocoate? They never responded because it’s impossible. So right then I knew they were covering up the surfactant. I also researched the sweet pea extract and there is no natural way to get that scent in their product using that. So that was strike 3 for me. These people are scammers.
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I literally had just asked them this the other week! I wanted to know the pH levels of their Shampoo offerings and I was told:
Extra Gentle Shampoo 5.5-5.8 pH
Daily Shampoo 5.8-6.2 pH
Dandruff Flake Removal 6.2-6.5 pH
Shampoo/Body Wash 5.5-5.8 pHThis raised 2 questions.. one how did they get Potassium Cocoate to work at a pH below 7? Given these are factual. And two, why no need for a preservative at that pH?
Interestingly enough I found some information that suggested Potassium Cocoate could be lowered into acidic territory when combined with heavy use of a solubilizer, in this case Caprylyl Caprylyl Glucoside would be it. I haven’t experimented on this yet but intend to do so. I haven’t bought their Shampoo to test the pH to see if they are factual pH levels, I may for experimentation.
Now the preservative part had me stumped and this thread may have solved the mystery.. they just may be irresponsible or untruthful. However I do have a question based on other information I’ve read. If a product is 70% or more surfactant would it need a preservative at a pH of say their 5.5? I’m hoping @PhilGeis could chime in here.
I had assumed this is how some Castile soap or saponified soap got away with less than a pH of 10. I have in my possession two Saponified Soaps, one a pH of 8.5 and the other a pH of 7.3. Both from what seem to be two different credible sources. Is this also irresponsible on their part?
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70% is pretty tough, esp. at higher pH - if manage appropriately - sanitized production as RM and transport and delivery (one way totes and drum liners, sanitized tankers, unloading and storage, etc. ).
They aren;t bad but please don’t have too much faith in castile soap or pH 10 as preserved. These are good examples of potnetially susceptible stuff that happily passes USP/ISO preservative tests. I’d not go much below pH 12 in presuming no problem.
I’ve seen Serratia contaminaton of liquid (true) soap and note the following recent recall. Note recent recalls for micro contamination (aeruginosa) of Liquid laundry and - both pH >10.
Castile Soap Towelette
Product is contaminated with Nesterenkonia lacusekhoensis
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This is what I had assumed based on other information I had read. So what would then be your recommendation for a preservative with pH of 10, let’s assume Castile Soap? Phenoxy?
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You could try a FA releaser (esp DMDM Hydantoin)- even CMIT - unstable but likely effective long enough without amines. Maybe phenoxy - I’ ve no epxerience wth it in context.
If in a pump package, it’s almost entirely a manufacturing issue. Once it’s in your system, it’s a devil to eliminate. How well in control are you?
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I am a bit surprised by the certainty that people have here in the OP and the replies.
In the reply from Carina Organics, they said their pine extract provided antimicrobial efficacy.
So let’s examine the pine extract parts from the recalled product vs the current products.
In their recalled product’s 2009 formula, they listed Pinus divaricata (pine) extract, Pinus banksiana (pine) extract, whereas in the subsequent formula you mentioned, they listed Pinus elliottii (pine) extract, pinus banksiana (pine) extract.
So Pinus elliottii replaced Pinus divaricata.
There are some studies showing anti-mold and anti-bacterial properties of some pine extracts.
Without exactly testing the pine extracts used by Carina Organics, or testing their products and subjecting them to the challenge test, I am a bit surprised that you and everyone else feel SURE that these formulations do not work to functionally preserve the products.
My conclusion from reading your post and doing a quick search on pine extract is that it seems hard to tell for sure yet whether their formulation is functionally preserved or not without more in-depth digging about pine extracts of various sorts, and even then maybe, without doing the challenge test on their specific products.
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Don’t be surprised or an apologist for BS. Lots of extracts have antimicrobial potential in some zone of inhibition test. There’s s nothing special re. preservation about ’em - including pine extracts. Efficacy has been studied in many product contexts and re. specifc components/putative actives. Even if effective at cosmetic use levels (they are NOT) - batch to batch concentrations are so widely variable there is no reproducibility in efficacy.
This is just another crunchy granola marketing bunch, ignorant of the risk their green BS brings to consumers - here infants.
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Yes, MIC tests better be quantitative, not qualitative, and in the right contexts. I would imagine batch to batch variability you mentioned is a variable that may indeed affect things like pine extracts, or at least make them more challenging to use consistently.
I am not being an apologist for BS, I was genuinely curious why people were so sure. Well, you gave one answer on the possible variability and MIC tests.
I actually did use Carina Organic’s shampoo and body washes some years ago and quite liked the products as a customer with a very sensitive skin. That does not mean, of course, that their products, if not suitably preserved, won’t have contamination issues. However, I am surprised that if their products are indeed very poorly (or not at all) preserved, why contamination during customer use is not visibly much, much more frequent. I mean, I’d really expect mold or cloudiness to be visible if their products are not preserved and I bring them in the shower. I’d have expected monthly reports of contamination and recalls, not once-in-a-few-years recalls. But maybe I was bathing in invisible bacteria, I wouldn’t know.
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Your expectations are not consistent with reality or apparently experience.
It should be intuitive that a preservative is necessary and the products do not include anything known. The 3 year effective and surprising pine extract preservation based on <i style=”font-family: inherit; font-size: inherit; color: var(-bb-body-text-color);”> natural antimicrobial and antibacterial properties from something in their backyard they extracted themselves is pretty tough to buy - esp. from an obscure bunch with a past record of contamination. It should have anyone with relevant experience scratching their head. Suggest you review pine extract compositions in the literature - there’s nothing magic.
Please don’t blow off “once in a few years” FDA report for contamination. This is serious and brands and minor brands skate by on this frequently - 1) they have to discover the contamination and 2) turn themselves in. Contamination as made is also function of failed manufacturing hygiene and not directly relevant to in-use risk. That you failed to observe spoilage in one experience is not a valid assessment of preservation. Shampoos are generally resistant to fungal contamination and bacterial contamination is often cryptic - unapparent . In-use studies are designed with n>>1.
Please don’t be superficial regarding microbiological risks. Folks have been blinded and even died (including babies) from infections acquired from contaminated products. Safety is a positive assessment that must be confirmed, not presumed until shown otherwise. I’d not offer benefit of a doubt excuse for extraordinary claims with no data.
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@PhilGeis Hi PhilGeis, of course, being superficial with microbial contamination or preservation is bad.
At the same time, natural extracts deserve to be assessed without prejudice, for or against it.
Blind belief in them leads to damage, but so it is the other way around. I am now under the impression that EVEN IF Carina Organics did find extraordinary pine extracts that do work well, their finding would have been dismissed by you in the same way without examination, because you already have ideas on pine extracts as a whole and there is no room for redemption. I prefer to remain more open and at least examine possibilities and data when available before making a more definite judgement on stuff. That’s just me, in general, we can take different approaches. Life can be more interesting when there are different approaches.
If Carina Organics said they extracted pine extracts from their backyard I missed it. But I was under the impression they did not. and if by getting pine extracts “from their backyard” you are simply being dismissive, well, I don’t know. They are Canadians, so they may have the best pine trees in the world in their backyards. No offense meant, if there is any Scandinavian, Russian, or East European friend here with proper pride in their own pines. ????
I did not expect me to be an unofficial spokesman for Carina when I wrote and I don’t intend to, but since you somehow trivialize my customer experience to n=1 bottle, let me at least clarify that I was, in the past, an avid consumer, probably used close to 10 bottles. So it is very minutely slightly more significant than n=1. Or one could say, ten times more, in which case both would be right. I wonder whether Carina’s pine extracts are at least 10 times better than your assessment in the same way, though, their extracts may still suck or be great, I simply don’t have data to tell.
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As an appreciation to your comment, though, here’s a bedtime reading that may be interesting to you, too. This discussion now got me interested in pine extracts, I think I’ll really start to dig a bit into pines.
This is the discovery from the first find:
MIC to S. aureus of pine needle extract, 2.5mg/mL.
That number’s not great, but is not terrible (not obviously out of the range for use).
Just the first one to find; more to follow. Enjoy!
“The dialyzed samples were isolated using ultrafiltration (MW 30,000 and 10,000). According to the results shown in Supplementary Figure S1, all ultrafiltered fractions (>30, 10–30, and <10 kDa) inhibited E. coli and S. aureus. Among these fractions, the antimicrobial activity of the sample ≤10 kDa in size was the highest. In addition, this fraction was most effective in inhibiting S. aureus (2.5 mg/ml) compared to E. coli (5 mg/ml) and showed the same results as the dialyzed samples.”
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8172577/
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Also, lock your door at night, because extvolat companies may come knocking at your door. 🙂
cosmeticsandtoiletries.com
[update] Pine Aqua's Extvolat Proven to Self-preserve
Gentle coaxing is what it takes to extract holistic plant properties, according PineAqua, Ltd. As the company explains, the resulting "monoproduct" serves as a water replacement for preservative-free cosmetics.
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Also, “Your expectations are not consistent with reality or apparently experience.” This is quite a statement to make to someone. If you continue along this line, Dr. PhilGeis, I will also tell you what is in my mind without a filter. 🙂
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I suggest you pipe down a bit. No need to flaunt your lack of experience.
So….back to basics…you are defending a company that has purportedly emulsified their mess with cetyl alcohol and guar gum? This really makes you feel warm and fuzzy…and you think they are playing with a full deck? Clearly you are defending a company that does not place ingredients on the INCI that they feel their customers will not find….in vogue.
I find it amusing…that you would suggest to the career P&G guy….what you think P&G would do or think? Help me out….I’m a little stumped.
You may find the mommy blogger sites…more to your liking.
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No.
Please read what I had written and take them literally without adding serious misinterpretations or putting words into my mouth.
I had merely asked why do you guys feel so sure about pine extracts not being effective as the preservative. I was looking for some scientific or at least rational discussion.
Not low-quality responses of “I’m the P&G guy,” or the “go find mommy’s blog” types.
In fact, I am disappointed by these responses and believe they reveal something about those who responded this way.
Answers to my question on pine extracts that I would have found respectable include:
-Batch-to-batch variability in natural products
-MIC may not be effective
-I have tested them and they were not effective
-Carina Organics record of lying,
etc.
The unacceptable answers, in my opinion, are:
-because P&G guy says
-because the expert says, I just believe it without using my own head to analyze anything
-because it’s a stupid company
-because I’m more experience than you
-because I want to believe so without data
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Dr Phil Geis wrote the book on Cosmetic Microbiology, literally. If he is skeptical of supposed preservative in an inci, there is definitely a good reason. If pine bark worked as an effective preservative, I think Proctor and Gamble would’ve bought it all up and you would see it in INCI’s all over the big box store shelves.
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I think he may indeed have a good reason, and I am glad I asked and got to hear his reason. As to what you said, I don’t think P&G would have necessarily bought pine extracts and use them EVEN IF they were effective, because they would be more expensive.
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Suggest you know little of P&G or pine extracts.
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Please stop - you clearly know nothing of preservation or P&G.
P&G and others have extensively researched naturals, extracts (incl pine), eye of newt and toe of frog both individually and in combinatorial assays. We chased some into extensive safety and efficacy testing - none met the objectives of safely and effeciutvel preservating products. Naturals generally don’t protect consumers, for whatever efficacy and composition are inconsistent batch to batch, naturally include components of safety cocnern, must be tested for pesticides and can be sourced from ag sweatshops in Far East. And please stop with the MIC’s - those have little relevance to in-product efficacy.
Yes Carina’s source is backyard <i style=”font-family: inherit; font-size: inherit; color: var(-bb-body-text-color);”>This ingredient (made in-house with the sap from local pine trees)
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@PhilGeis PhilGeis, if you are an American, you had better read and respect the First Amendment: freedom of speech. Applies to you, too, @Graillotion.
Trying to literally shut others up when they ask questions, engage in discussions, voice their opinions that may be different from yours, is immature and does not foster growth in anyone.
ESPECIALLY in an open forum, which, by definition, is: “a place, meeting, or medium where ideas and views on a particular issue can be exchange. This is neither your personal journal, nor your personal shrine where what you say is God’s words. This is where fact and data-based discussions as well as rational and civil exchange of ideas should prevail, not blatant “I know stuff you don’t, so shut up” kind of rudeness.
You could have, in the first place, share what you have written here about pine & P&G in previous replies, but you had not done so. In previous replies, you just tried to shut me up without sharing any explanation or knowledge.
Furthermore, what you said is factually not true. Not all natural extracts have no efficacy in practical uses.
I, for one, know of one or two that work extremely well.
You seem to think that your knowledge and your world is the absolute truth. Hence that defines your own limitation and boundary you will never cross.
Cheers.
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Also, are you saying that because P&G has researched natural compounds extensively, no other companies, startups, entrepreneurs, and scientists can find something that P&G has failed to find?
I disagree on that point.
Disruptive innovation often happens not in huge companies, but from smaller players and innovators who have more freedom to try things and who have more freedom to think differently. And those who are humble enough to NOT think:”I’ve tried everything, I know everything the best. No other person can possibly know something I don’t in this.”
I am not saying Carina Organics is such an innovator (as I’ve stated multiple times, I need more data and probably need to try their real products and pine extracts in order to specifically judge this case).
However, there were, are, and will be innovators who find things that P&G fails to find.
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Regarding: “And please stop with the MIC’s - those have little relevance to in-product efficacy.”
I beg your pardon-MIC is an extremely relevant metric for antimicrobial efficacy in science.
It has high relevance to in-product efficacy in cosmetics if you apply it right.
Knowing MICs is an extremely valuable place as a starting point to judge whether an antimicrobial substance has even a potential or not in the beginning. If something has an MIC of 1g/mL, and if the substance is expensive, one should automatically know that it is out of bounds, P&G or not, because it will likely not be cost-effective.
However, if something has an MIC of 0.0001g/mL, and if the substance is cheap, then you know this is a promising candidate to start with.
If a pine extract has the MIC of 2mg/mL, that is within the range of possible uses in cosmetics; next, elements such as cost, compatibility with other ingredients, stability need to be tested.
MIC is a very valuable starting point. And so is the cost of the molecule.
All these are part of science and rational decisions in formulating.
MIC is the most widely used metric in antimicrobial science and it has a place in cosmetics. It is not something that should ever be dismissed with “please stop; MIC is irrelevant; you know nothing about P&G and cost” type of comments.
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As I said - you know nothing of preservation or apparently the 1st amendment. You’re free to offer total BS as with your affection for MIC.
MIC’s are pretty meaningless - MBC might have some little relevance but efficacy in a agar/broth based test is not efficacy in a product. Please recall ISO/USP/EP whatever demands some degree of kill not inhibition. Every crappy preservative on the market shows great and useless MIC data.
Right - these folk discovered gold in their back yard. They’ll not let you see it or provide chemical data confirming - just a gee whiz cute comment.
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MICs are relevant because one can first read what these numbers are to get an initial idea of plausibility (yes from broth and agar assays); when MICs are promising, then one can proceed to do one’s own work in testing killing efficacy in more realistic settings, such as in-product preservation efficacy.
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I believe the issue with MIC values are that they are mostly from suppliers. For me, suppliers info is not a good source of info (their main goal is to sell). Even if you compare MIC of same compound from different suppliers, you’ll see there’s difference. When it comes to real worl (bypassing challenge tests whith have very limited utility), in-use tests are usually done by recovering hundreds-thousands of commercial product that consumers used under normal conditions, and then micro testing them. This is usually done only by large companies because it’s very expensive and require a large number of people involved. That is why P&G and others stuck to their preservative system for long, not because they are old fashioned (trust me, they tested everything), but because only they can gather data that other companies can’t to validate their real efficacy. Cheers!
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Yes, fully depending on MICs reported only by sellers would be quite risky to base one’s own product development, I agree. There are many academic studies that examine MICs of natural substances as well, though, with no conflicts of interest. Even these are not to be trusted fully. Nevertheless, reported MICs are useful for parties who have means to further conduct tests and studies on these substances on their own after. Not very difficult for a team with microbiologists/cosmetic formulators combined. Interesting to know about the in-house testing method of P&G. I think it’s a very good way to test.
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Waste of money. Have a lab examine it and sue for adulteration. Did nothing for my customers toner but just a name on label - we have to base products for efficacy and nonetheless why give Russia money for pine water
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Unfortunately, many modern companies do not care about the health of consumers, and sometimes do not even test their own formulas! This is an extremely blatant violation of the principles of healthcare and humanity in general. And there’s no need to talk about environmental pollution
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Think the big guys all conduct data-based human and env safety assessments.
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This is why people should generally buy from Big Corporations rather than small, indy beauty brands. Big corporations do not skip tests and are the most safety tested products on the market. Some smaller companies are often underfunded and just assume their products are safe without testing.
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Hi @Graillotion thanks for sharing this, I was to buy this product, I changed my mind after your comment.
Do you know any good organic brand for shampoo and conditioner?
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Try PHIQUE brand of shampoo and conditioner. https://phique.com/
phique.com
Phique products are backed by our 100% Quality Guarantee. Our scientifically formulated products are the result of thousands of prototypes and tests which have
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Good point - as MoCRA will make folks more accountable for safety up front.
I know nothing of “assignment bro” - appears to claim service as academic writing resoruce rather than safety assessment.
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