00:15 --> 00:35
Speaker 1
Hello everyone and welcome to the new podcast of Intertek's Assurance in Action. My name is Ophélie and I am here today with Vaguelis. We are both regulatory affairs specialists at Intertek.
This episode is dedicated to the importance of keeping a raw materials portfolio up to date, especially considering perpetual regulatory changes.
00:35 --> 01:17
Speaker 2
Hello Ophélie.
As long as their raw materials are used and available on the market cosmetic brands, manufacturers and suppliers of cosmetic raw materials must comply with all regulatory requirements, including the European cosmetic regulation, CLP and IFRA. However, while attention is often paid to new raw materials entering a portfolio, existing raw materials may be neglected. Cosmetic companies need a proactive approach—not only towards compliance of new materials, but also towards updating existing materials in their portfolio.
01:17 --> 00:35
Speaker 1
And yet, as we all know, regulations like these change—and tighten—frequently. So, how can you make sure your portfolio stays up to date?
00:15 --> 01:34
Speaker 2
But first, can you tell us a few words about the recent regulatory changes?
01:34--> 02:18
Speaker 1
In 2023, the European Commission cosmetic regulation (1223/2009) was affected by several changes: the publication of the new allergens list, the growing awareness of environmental concerns, the new REACH regulation regarding environmental allegations, and new restricted or prohibited substances with OMNIBUS. You can find all our podcasts on these new regulatory items on Intertek's website.
These regulations dictate new requirements on all types of ingredients, including vegetable oils, polymers, perfumery ingredients, and more. So naturally, they impact various types of cosmetics, including perfume, skin care products, etc.
02:18 --> 03:19
Speaker 2
Ok, you might think, "I'll adjust my raw material to conform with the new requirements and move on." Well, yes and no.
Indeed, once a new regulation is published or amended, first you must evaluate whether the regulatory changes apply to your raw material and adapt your material if necessary. However, changes made internally to raw materials—for example, changing the manufacturing process by including a new solvent— may also impact your documentation and other regulatory requirements. A new manufacturing process may change the composition, impurity levels, or residual solvent levels of your raw material, not to mention qualities like color or physico-chemical characteristics. Specification sheets should therefore be updated if there is any change that requires it.
03:19--> 03:41
Speaker 1
As another example, to reflect a new manufacturing process or an organic certification that you recently obtained, you may consider changing the trade name of your raw material. In that case, you must change the name on all documentation related to your material, or otherwise establish a certificate of equivalence, to remain compliant.
03:41-->03:48
Speaker 2
Ok, so how do I determine the full impact of a regulatory change on my raw materials portfolio?
03:48-->04:31
Speaker 1
Any modifications, whether regulatory or resulting from changes in the raw material production, require updating the raw material’s reference file. For a finished product, several elements will be impacted by modifications, including the labelling, the safety assessment, the Product Information File, and the CPNP (Cosmetics Products Notification Portal) notification linked to the product.
In short, as soon as a new regulation is published, it is useful to carry out an impact analysis on a raw material portfolio to determine any necessary action for compliance. Such changes can impact multiple departments across a company, like regulatory, R&D, manufacturing, quality and even safety.
04:31-->04:41
Speaker 2
So, to keep a raw material portfolio up to date the key is anticipation, but it must be complicated to stay constantly informed.
04:41-->04:58
Speaker 1
Faced with constant regulatory changes, keeping your raw material portfolio up to date can be a daunting task. External tools can help keep regulatory watch. They’ll ensure that you know the important developments as they happen and can implement action plans to meet any deadlines.
04:58-->05:22
Speaker 2
It is important to homologate your raw material portfolio on a regular basis. Outsourcing regulatory activities is also possible. To meet a one-off need or to optimize your processes, at Intertek our experts can provide you with their regulatory and toxicological skills through various services that you can find on Intertek's webpage.
05:22-->05:28
Speaker 1
Thank you Vaguelis for joining me and thank you all for listening! We hope you enjoyed this podcast!