Cosmetic substances and devices encompass a wide range of products which often overlap with other product-types and regulations, namely Biocidal products regulations and Medicinal/Pharmaceutical product regulations in the case of cosmetic substances, and Medical devices regulations and Electrical and electronic equipment (EEE) regulations in the case of cosmetic devices.
This regulatory overlap means it is not always clear which obligations apply to these products. With a growing market for general consumers, the development of new products, and a growing awareness by regulators of their unclear status, it is more and more essential to understand how these products are currently regulated and what actions are being taken to improve their regulatory status, to help avoid negative impacts such as product recalls.
We will break-down the current regulatory situation for borderline cosmetic substances and devices in the US and compare it to the situation in the EU. We will then look at a range of borderline cosmetic products and determine which obligations would apply to them. Finally, we will investigate what actions are being taken to better regulate these products and how they will affect companies.
The session will cover
Introduce the regulatory landscape of borderline cosmetic products and devices.
Explain how to classify borderline products within this landscape to achieve proper compliance.
Identify what actions are being taken and how these will affect the future of these products.
About the presenter
Jone Santin Azcona, Senior Regulatory Consultant
Jone joined Yordas Group after finishing her PhD in Biology from Newcastle University. She is a Senior Regulatory Consultant as part of Yordas Group’s Product Stewardship team.
She leads the Global Notifications team as well as multiple long-term client projects. She works closely with clients on regulatory matters mainly focused on consumer products.
