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Speaker 1
Hello everyone, welcome to Assurance in Action podcast. Today’s podcast is part of our Cosmetic industry series.
Pandemic, climate crisis, political conflicts…the historic events of our era have caused raw materials supply issues and shortcomings across industries. Companies—including those in the cosmetics industry—have been forced to react urgently and make substitutions, often relying on what is known as “multi-sourcing.”
With that, we welcome you to our podcast on raw materials multi-sourcing in cosmetics, also called diversification or raw materials equivalence. My name is Annaelle, and I am accompanied today by Cyndia.
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Speaker 2
Hi everyone, I'm Cyndia, and we are regulatory experts with Assuris, a regulatory division of Intertek.
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Speaker 1
Today we are going to talk about multi-sourcing of raw materials but before we begin, we are going to define it.
Multi-sourcing is an approach that allows for diversification, ensures greater provision of raw materials, and warns of potential stock issues. Multi-sourcing enables companies to identify new, equivalent commercial-grade raw materials and apply them to an existing raw material in the portfolio.
Cyndia, how is multi-sourcing impacting the cosmetics industry, specifically the regulatory aspects?
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Speaker 2
In the cosmetics industry, new raw material sources need to be checked and validated by a different division: Marketing, Procurement, Quality, Development and Regulatory.
In order to meet industry regulatory requirements, new raw material sources must pass a validation process. This process ensures that new materials are comparable to existing materials. These conditions should be gathered to validate the equivalence of the new source in relation to the reference source.
You will then ask, what are the requirements for analysing multi-sourced raw materials?
To analyse multi-sourced raw materials, we first compare the International Nomenclature of Cosmetic Ingredient (INCI) decomposition, quantitatively and qualitatively, as well as toxicological evaluations, of the new raw material source to the reference source. The multi-sourced raw materials must have the same composition as the existing raw material source in order to establish equivalence, that is the raw materials must have the same INCI and the same distribution in terms of percentages.
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Speaker 1
Another important point is to check the standards, certifications, and labels. To verify the equivalence between the two Raw Materials, the certifications and labels must meet, at minimum, the same standards as the reference raw material. Examples include, COSMOS certification, or Halal/Kosher labelling.
Next, the respective manufacturing processes for the new Raw Material and the reference Raw Material are compared. For this, the raw material files must contain detailed methods of production.
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Speaker 2
Another essential point is to analyse the impurities and potential contaminants to determine the equivalence of the impurity profile between the new raw material and reference raw material
Finally, other criterion as origin and naturalness of the new raw material are also compared.
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Speaker 1
Is a toxicological analysis performed on the new raw materials?
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Speaker 2
The toxicological impact of the new raw material is verified upstream thanks to the regulatory controls. Therefore, there will be very little toxicological impact when a new raw material is used in the multi-sourcing method. From a toxicological point of view, the differences are negligible as long as the compositions of the two substances and the impurities profile are equivalent.
Annaelle, from an analytical point of view, what is important to check to validate a new source? What tests are performed?
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Speaker 1
The certificates of analysis and the methods of analyses between the existing and the new raw material source must be compared. The analyses for the specifications must be obtained on three batches from three different productions at least.
Other parameters must also be studied, such as the duration of stability of the material and the storage containers because these parameters can vary the microbiological counts and can make the equivalence of the materials non-compliant.
Cyndia, Is there an accepted margin of difference between the new and reference raw material sources or must the results be strictly identical?
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Speaker 2
In general, differences can be identified, but only lower and/or acceptable levels can be used to validate the equivalence of the raw materials. For example, it is possible to identify different microbiological decompositions, but only lower levels than the reference material will be accepted. In the same way, new impurities may be encountered but they will have to be studied from a regulatory and toxicological point of view in order to ensure that there is no impact on the material and therefore on the equivalence.
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Speaker 1
To conclude on this topic, multi-sourcing allows to simplify, even to optimize the management of suppliers and raw materials stocks by allowing to reduce costs, to minimize the risks of disruption and by improving performances while respecting a precise specification. With a long-standing expertise in raw material homologation and diversification, our Assuris and Lacomed teams can provide you with support in this process, from the implementation of the raw material equivalence specification, through the realization of tests, to the study and conclusion of your files.
Thanks for the listening and have a nice day.
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Speaker 2
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