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Speaker 1
Hello everyone, welcome to Assurance in Action podcast. Today’s podcast is dedicated to cosmetic industry and will be focusing on allergens. In Europe, cosmetic product commercialization is ruled by the European Parliament and Council regulation of november 2009. At the moment, 26 allergens are listed in the annex III of this cosmetic regulation 1223/2009/EC. Following an opinion of the SCCS on the 26 allergens dating from 2012, the European Commission issued a public consultation that suggested to modify the annex III by including 61 additional contact allergens. My name is Annaelle and I am accompanied today by Mathis and Christel
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Speaker 2
Hi everyone, and thanks for the introduction. Annaelle and I are regulatory experts within Intertek Assuris team
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Speaker 3
And I’m Christel, LC/GC chromatography field manager at Intertek LaCoMeD analytical laboratory
01:27 --> 02:19
Speaker 1
As mentioned, the main topic of this podcast will be the allergens and more precisely, we will focus on the pending regulatory update. First, what is an allergen?
Allergens in cosmetics are substances that you can find in few products. These substances might induce an allergic reaction on sensitive skin. With the annex III update, natural and synthetic extracts will be added to the list to minimize the risk of allergies. Contrary to the original 26 allergens, these extracts are composed of several substances and are considered allergenic as a whole.
Mathis, can you tell us what will be impacted by the addition of allergens in the cosmetic regulation?
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Speaker 2
Today, if one of the 26 allergens listed in the annex III of the European cosmetic regulation is present in a raw material and/or in a finished product, it must be declared in the CPSR (Cosmetic product safety report), the PIF (Product Information File), and also mentioned on the labelling and it is necessary to notify it in the CPNP (Cosmetic Product Notification Portal) declaration. With the addition of 61 new allergens, the annex III amendment will impact these elements. An update will be mandatory if a raw material and/or a finished product contains one of these additional allergens. Particularly the raw material file will have to be reviewed as well.
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Speaker 1
Ok, I see. And by the way, do you know when this regulation will be enforced?
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Speaker 2
No, the amendment to Annex III of the Cosmetic Regulation has not yet been published. The authorities are working on the subject and the update is expected during 2022. That is why we recommend our customer to be prepared as well as possible for this change and to make an impact analysis on their raw materials and/or finished product to anticipate. It will be necessary to verify that the finished products respect the regulatory thresholds for these 61 new substances that is to say: 10 ppm for non-rinse products and 100 ppm for rinse products.
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Speaker 1
Indeed, your are right, cosmetics players need to anticipate but how can they quantify these new substances ? Do laboratory have already developed analytical techniques ?
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Speaker 2
Yes, Our LaCoMeD laboratory can now perform this type of analysis. Christel, can you tell us more about the analytical method you use to identify these new allergens ?
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Speaker 3
Yes, as you mentioned, methods have been developed to meet the need for allergen analysis in cosmetic products. The main objective of developing our method was to be able to provide reliable, sensible, and specific data. This is a delicate task since the samples are complex mixtures. Therefore, the analysis must be robust to matrix effects and adapted to an appropriate concentration range. There are several categories of samples, such as, for example, raw materials with a low amount of allergens where the LOD Limit Of Detection/Limit Of Quantification will be in the ppm range, or essential oils used in the manufacture of cosmetics with a quantification range from 20ppm to serveral percent. In the LaCoMeD laboratory we have therefore developed an analytical technique based on GC-MS/MS (tandem mass spectrometry) with MRM (Multi Reaction Monitoring) technology that allows us to obtain accurate and precise results in the determination of allergen concentration
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Speaker 2
And what are the limits of the method?
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Speaker 3
Classical methods are not very efficient because of matrix effects: the presence of interferents (molecules that have the same affinity with the chromatography column used) can lead to the overestimation of an allergen, we call that a false positive. This problem has been solved with the development of our analysis method. However, among the 87 allergens, 30 are natural extracts and remain for the moment difficult to quantify. Thus, the developed methods we have are effective for the remaining 57 allergens that are the chemical substances. The natural extracts can still be identified by the Raw Materials supplier and reported if present.
06:29 --> 07:35
Speaker 1
Thanks for your clarification, which is very useful. To conclude, the Official text is expected for 2022 but for the moment it’s postponed from quarter to quarter. However, it’s still recommended to start preparing for the addition of these 61 new allergens. As we have seen together, methods of analysis for 57 allergens are already operational. It’s possible to assess the impact of this change, for example by collecting data on raw materials to determine which formulas will be affected. Obviously, not all raw materials are concerned by allergens, the impact is more important on ingredients such as essential oils and plant extracts. Solutions exist to help you with these various preparation tasks in view of the new regulations. I invite you to contact us if you need support.
Thank you Mathis and Christel for this great conversation on allergens in cosmetic products and thanks to our listeners
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Speaker 2
Thanks for listening, bye
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Speaker 3
Thank you, see you
