Cosmetic Shelf Life Testing

[MadRob]

Hi all!

I have two formulations of a cosmetic "soap" (not a true soap based on the reg. definition) that are identical in all ways but the flavor. I have years worth of shelf life data on the original formula flavor, and am trying to determine how risky it is to use that data to infer on the shelf life of the new flavored formula? The original formula has never had any consumer issues, nor any positive micros testing, etc. (not to say it couldn't happen!). It would save thousands in testing, which is what my board is particularly interested in.

 

[Ed Panek]

Does the supplier of the added flavor(s) have any data on shelf life?

 

[MadRob]

Kind of, both provide a statement of "The character of this product will not change significantly for at least 12 months when stored..." Both are also from the same manufacturer. The original formula achieved a shelf life of 4 years beyond the raw material's.

 

[v9991]

Hi all!

I have two formulations of a cosmetic "soap" (not a true soap based on the reg. definition) that are identical in all ways but the flavor. I have years worth of shelf life data on the original formula flavor, and am trying to determine how risky it is to use that data to infer on the shelf life of the new flavored formula? The original formula has never had any consumer issues, nor any positive micros testing, etc. (not to say it couldn't happen!). It would save thousands in testing, which is what my board is particularly interested in.

Systems shall support two pronged approach
NO.1. its between regulatory requirements and expectations. Requirements are not always explicitly spelt out; and where required, the practices to be complied with
No.2 is the "risk to the product and process"; viz., consider the nature of the new flavour, interaction of the flavour & ingredients; effect of the process on it etc.,
imho, based on the risk assessment, we are required to place the batches on stability, albeit with reduced frequency and scope of testing. whether we perform the analysis or ; not they will help as stand by for any possible complaints/problems which could be discovered .

 

[Arrhenius]

Likely, the fragrance concentration would be a very low concentration in the overall formulation of the soap. As long as the fragrance doesn't somehow degrade over time into a compound that causes some sort of skin irritation (very unlikely), then I think there is little risk in leveraging existing stability data, as opposed to running a complete new stability study. It is possible that the soap no longer has a scent after aging a period of time, so any information you can obtain from the fragrance vendor regarding shelf-life of the raw fragrance would be useful, as well.

 

[cosmeticqg]

Hi All! This was an interesting thread. @MadRob, the question you pose pertains to stability. Are you also looking to take a risk-based approach to justify eliminating other type of tests? Any chance you can share your risk assessment template? I was looking to create one that would help create a testing plan whenever there are minor product changes.
Actually, any information anyone can provide would be helpful. I work for a company that conducts all required testing on all the products launched, regardless of how minor the changes are. Thank you.

 

[MadRob]

@cosmeticqg For this particular cosmetic we only need to conduct stability testing, but I will likely end up doing a modified version of our risk assessment. Unfortunately our risk assessments are more relevant to medical devices, and I am not able to share them. But I would also be interested in hearing about or seeing any other perspectives to this!

 

[Ronen E]

Apparently the fragrant is mixed with other ingredients during production, so on top of considering the fragrant's effective life and it not degrading into a harmful compound (as unlikely as that is to happen), consideration should be given to any possible interactions with the other ingredients in the finished product, and effects on the manufacturing process, both short- and long-term (over the finished product shelf- and use-life).

Shelf life is typically a specification performance requirement. Addressing such a requirement is typically part of design verification. Theoretical analysis is typically much more robust, as well as more economical than testing. Shelf life testing, be it real-time or accelerated ageing, is a kind of testing, so it's most likely less robust and possibly more costly than a well-thought-through desktop analysis (not to mention longer in duration).

I recommend a thorough theoretical chemical analysis, to address any interactions between all ingredients, including environmental effects, during production and over time thereafter (don't forget transport and transient storage, which often involve uncontrolled temperatures etc.). It's important to account for the manufacturing environment and effects, as part of this analysis. A theoretical analysis would make any subsequent risk analysis much more informed and robust, and would make much more sense to me than rushing to do lots and lots of testing (creating a huge heap of data as a distraction, instead of hitting at the source with an elegant blow).

Hopefully suppliers will be able and willing to support such analysis with formulation data.

 

[Jen Kirley]

I agree with Ronen E. The fragrance is different because of what? If it is a naturally occurring substance such as vanilla, its chemical interaction might differ from another other fragrance such as citrus. The processing results could differ, long term stability might vary. Further chemistry study and testing is required to understand it fully.

 

[cosmeticqg]

Thanks, @MadRob! I think one of the problems my company faces is that we have a 'turn-key' model, where our suppliers are technically responsible for providing products that meet our (manufacturer/customer) requirements. However, we also have a strong new product introduction team who often disagrees with the suppliers on how development takes place. This has created much tension over the years and suppliers are not as open to sharing design files. Ronen E., you said it well, suppliers have to agree with these type of analysis.