Microformulation
Forum Replies Created
-
Without a stability chamber, you will be best off sending this testing to an outside lab such as Microchem. As far as protocols go for Cosmetics, most follow the guidance of the PCPC. Perry did a great webinar on it earlier in the year.
-
That would be an OTC product and not one you could legally produce.
-
It was. Now I am trying to parse my response so that I can explain to them it is a non-issue and I can get the product approved.
-
This is nonsense. I think as you read more about the materials in the scope of Cosmetic use you will quickly see how they are safe for use.
-
That pH might be a little high for a topical, arguably. However being that SAP is most stable at a pH of 6.5, I would not aggressively adjust the pH,. SAP is recommended with a buffering system. These can be a bit tricky, but if you review your Chem 101, the concept will come back to you.
-
Your ingredient deck should be from ingredient at the highest percentage to the lowest percentage in descending order. After the 1% line you may list them in any order although I was trained to leave preservative, colors and fragrances at the end. Looking at your ingredient list, I don’t believe it is in this order.
Your nomenclature should use INCI notation. Even in this case, INCI notation would be more helpful. Some examples of non-INCI notation;
- EDTA. Was this Disodium EDTA or Tetrasodium EDTA? They are different products and used at different pH levels.
- Vitamin B3. This is incorrect. The proper INCI name is Niacinamide.
- Vitamin E. This should be most likely Tocopherol.
- Aristoflex velvet. This is a trade name, not an INCI name. The INCI name for this material is Polyacrylate Crosspolymer-11. Trade names are never used in an Ingredient deck.
- Phenonip is another Trade name. The INCI name is likely
Phenoxyethanol (and) Methylparaben (and) Ethylparaben (and) Propylparaben (and) Butylparaben (and) Isobutylparaben, although there are other types of Phenonip (It is a line of preservatives from Clariant. In this case it is especially important as your customers will want to know the contents of the product. Parabens are a touchy but controversial subject but you do need complete transparency. - Silicone Oil. With the information here, there is no way of knowing what Silicone oil is. It is actually the first time I have seen that nomenclature. You would want to determine which silicone you used and then notate the proper INCI name.
- Perfume. This is not the correct nomenclature. In the US/North America it would be recorded as “Fragance” and in the EU as “Parfum.” This assumes you used a premade synthetic fragrance. If you used Essential oils, the INCI name for each Essential oil would be used.
- Distilled Water. The INCI is simply Water. Through proper practices and knowledge you will select an appropriate type of water. This however is not reflected in the Ingredient declaration.
- Various misspellings but I will not dwell on those as they could be easily corrected.
I know this sounds picky, but it gives the appropriate information to your clients, would better demonstrate to other Formulators what you use, is technically correct and abides with FDA Guidelines. There are similar guidelines in the EU.
-
As far as pH goes, purchase a meter. The strips are simply not feasible. A meter that can be calibrated can be obtained through several sources.
-
1. Not enough information to answer. As Bellassi has pointed out, there are multiple factors to take into account.
2. Ibid or same as Number 1.
3. Rot really isn’t the correct term. An improperly preserved product will be susceptible to growth off bacteria, yeast and mold. In the case as here where there could be a high oil content, there could be the need for an anti-oxidant. An improperly preserved product could change color, odor, exhibit instability or even worse be harmful to the client. Again in this case not knowing all the factors makes it difficult to fully predict.
4. Each product has different usage levels and even the same product has different usage levels for different applications. There is no blanket answer but the distributors provide extensive documentation specific to the product.Lastly (and not numbered since not truly a posed question) you should look at Marketing forces as a factor in selecting your preservative. My best example would be parabens. Honestly avoiding parabens has a poor scientific basis but is rather a reaction to a flawed study. Albeit was flawed, it led to a bias against these ingredients.I submit that this market shift has made Cosmetics less safe rather than more safe as we now have to avoid an effective class of preservative. With this in mind, look at some of the issues with Methylisothiazolinone (MIT for short). They are not as simple as the consumer would believe, but it is a rising issue nonetheless. Don’t make market forces the SOLE factor in selecting an ingredient. Keep in mind that performance and cost are equally important as well.
-
I know we come off as harsh, but it is unintentional. If someone demonstrates that they have a lack of the fundamentals, we will strongly urge them to learn the Fundamentals before proceeding. If you were instructing anyone in a new skill, say tennis, you would also make these demands. In today’s market where some of these processes are not appreciated for their difficulty or their need for the supporting basic skills, this concept is lost. Remember, there is inherent risk in all these products.
Also, many of the experts have worked in Commercial settings and have seen the benefits of proper record keeping (wt/wt) and procedures. This makes it apparent that rather relaxing the technical level of the board to be more inclusive, in the long run there is more to be gained by asking participants to rise to the higher, existing technical level.
We see so many want to proceed in dangerous areas without the proper background. As an analogy, if a Physician saw me attempting to pry my appendix out, I truly hope that they would not refuse to stop me out of deference to political correctness or the fear of offending me.
I educated myself on the processes and must have spend untold hours in
research on the materials, processes and techniques, and the guidance of
the group here was the starting point for me.That demonstrates the result that makes us comfortable and the real goal.
That said, I am glad you persevered and made some great products.
-
“What else should I include, do you think?”
A more stringent claims substantiation process?
-
Lactic acid is not adequate as a standalone preservative. Decreasing the pH can assist as part of your preservative system but it should be coupled with other methods as well.
Don’t make the mistake of believing Food preservation has direct parallels to Cosmetic preservation. Processed food can be packaged more securely and they also use a great deal more preservation strategies based upon free water content. We hear about free water (Aw) in cosmetics as part of a preservative, but it is much more common and feasible in Food preservation. That is why their is a separate field, Food Science, a separate discipline entirely.
-
There is a more stable Vitamin C derivative (Sodium Ascorbyl phosphate). While it is more stable, it can certainly degrade over time, especially if formulated at an improper pH.
I would suggest reading a summary article about Vitamin C, it’s derivatives and the proper Formulation techniques. This is a huge area and it seems some more reading in regards to the topic could be beneficial.
The final pH of this product would be great to know, especially when you also consider the pH requirements of Niacinamide (improperly listed as Vitamin B3) which is in the Formulation. There are several other improper nomenclatures in the ingredient deck as well.
-
Again, I do not feel comfortable assisting on such a dangerous product without someone having a strong Technical background. Wt/wt notation is basic. Understanding starting formulation is key.
-
No offense, but if you are confused by Formulas that use wt/wt notation, you have a great deal to learn before attempting a dangerous product like a 15% peel! Please do not attempt this yet or hire a Consultant! This is a potentially dangerous product.
-
Many small brands tend to retain the manufacturing and packaging in-house, even in many cases where they need to pivot to Sales and Marketing and outsource these functions. As such, jars are a more attractive option on the surface. They are more easily sourced, easier to fill with adapted equipment and can be more feasibly labeled by hand. Since many of these smaller lines are still evolving and are only just getting exposure to the mainstream market, they will defend these packaging options out of necessity.
-
@Bill_Toge Thank you for the references.
-
From Colin’s Beauty Page’s. Colin is an outstanding Cosmetic Chemist and a great reference on EU Regulations;
-
No, but if you do an IFRA declaration I believe you have to claim it. Honestly I don’t have the EU limits memorized BUT I know where to find them should I need to. If you really want more details, David Steinberg’s book covers the regs in depth.
https://www.amazon.com/Preservatives-Cosmetics-Third-David-Steinberg/dp/1932633944
The take away is that it is a preservative. I will say at least on my part these preservative free claims make me leary. In most cases they are using something that has preservative properties but hasn’t been formally recognized as such. Also, any reticence with preservatives can generally be overcome by stressing the safety aspects of proper preservation. I think that FSS does a model job of this in their statement.
Lastly, I see more and more Home Crafters with moderate experience attempting to justify “preservative free” wrongly simply to fit their underlying Chemophobia. In almost each case where I stress the need for safety and proper preservation to these “audiences,” invariably someone will cite a commercial product and say “they don’t use a preservative.” In most cases they do, but it is a less common or older preservative and they don’t recognize the INCI names. A great example of this is Biovert (Glucose & Lactoperoxidase & Glucose Oxidase). Once you identify the preservative they will invariably cite another product with a preservation strategy they don’t recognize. In the end, they are simply exploring loopholes in order to meet what they feel is an absolute market trend (my customers don’t like preservatives). This overlooks safety and is really outside of their areas of experience.
-
-
It is benzyl alcohol (an Organic alcohol preservative) combined with preservative boosters.
To demnostrate my assertion, here is what Akema describes the product as “It is a synergistic combination of well established preservatives with
preservative boosters that enhance the antimicrobial effect and add
emolliency.”Reference: http://www.akema.it/preservatives.htm#KEM_NAT
Hence, call it a PRESERVATIVE.
-
No, especially since the product is a preservative. That is not under debate here. Also per AMT, they begrudgingly admit an anti-microbial is treated as a synonym for a preservative.
These claims should be avoided altogether.
-
It is great to see such a responsible response. Many distributors would have stuck to their position regardless or just not responded. I am glad to see FSS step up and show some integrity.
-
Just by the fact that they are using and endorsing Silver (argentum metallicum) makes me a little bit leary. Again, I share Belassi’s opinion that it is a poor Formulation. That silver will aggregate with other materials and its efficacy is not what it promises. This is the reason it is used at Homeopathic (ridiculously low) concentrations. Hopeless really said it all.
Also if they are endorsing a “Shake Well” warning, this is an issue as well. These warnings have poor compliance and as such the client will likely get inconsistent levels of the raw materials from dose to dose, -
Those are both great books and great references.
Here is also a presentation that David Steinberg did for SCC. The usage trends of the preservatives is out of date since the presentation is from 2012. However these usage trends have been updated since then and even posted recently in this forum.
My advice in learning about preservatives would be first to learn the functional “groups” (for example Parabens, Formaldehyde donors, Organic acids, etc.) and some representative raw materials. This is covered well in the presentation. There is also guidance of the max levels and appropriate usage.
Once you know these functional groups I think you will see that any number of distributors be it Schulke, Ashland, Lonza, etc. will have a line of preservatives which will serve the needs of almost every Formulation. You may find that you buy 4 to 5 separate products, but these are generally available in those lines.
Look at the Cosmetic Market as well as your potential clients. In this step you will begin to see the market forces (paraben free, etc.) that will contribute to your preservative selection. You may have a demand for naturally compliant preservatives. Be pragmatic though. You do need to address your clients concerns, but NEVER let market forces influence you to create a compromised preservative system. In some Formulations for example, parabens are simply the best solution.
Next, learn and follow the general concept of the “Hurdle Technique.” Again this is covered in the link. Simply, the preservative chosen is not the sole piece of a preservative system. Other factors such as pH, chelants (that will answer some of your EDTA questions), packaging and other issues should be taken into account.
Once you have your preservative system, move on to the rest of the Formulation. Preservation is just one factor of many in creating a successful formulation. Don’t concentrate on the trees and miss seeing the forest is a great way to prioritize your efforts.
Lastly, once you have a final Formulation, don’t hesitate to test your preservative system with outside challenge testing.
We have an obligation to create a safe product. This can be done with the raw materials available and while meeting marketing demands without cutting corners. Don’t feel free to compromise on this safety.
-
You will not find one preservative and/or preservative mixture that will preserve each and every Formulation. This is a simplistic approach. Also, you need to do some reading as the preservative is only one aspect of a preservative system.