Critical Catalyst

Is Aluminium in cosmetics safe for human health ❓

The SCCS has issued its Final Opinion on Aluminium safety in cosmetics. Safe use levels:

◦ Non-spray deodorants/antiperspirants: 6.25%

◦ Spray deodorants/antiperspirants: 10.60%

◦ Toothpaste: 2.65%

◦ Lipstick: 14%



Read full article: https://shorturl.at/IQfga

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Será o alumínio em cosméticos seguro para a saúde humana ❓💄

O SCCS emitiu a sua Opinião Final sobre a segurança do alumínio em cosméticos. Concentrações consideradas seguras:

- Desodorizantes/antitranspirantes não aerossóis: 6,25%

- Desodorizantes/antitranspirantes em aerossol: 10,60%

- Pasta de dentes: 2,65%

- Batom: 14%

Protetores solares em aerossol e formas nano de alumínio estão excluídos desta opinião.

Leia o artigo completo: https://shorturl.at/IQfga

The MDCG 2022-19 indicates a series of templates that should be used for performance study applications under the , while the respective module is not fully functional.

You can check below the required documents for application and notification of a Performance Study under the EU IVDR.

https://criticalcatalyst.com/application-and-notification-of-a-performance-study-under-the-eu-ivdr-required-documents/

The Commission published the Implementing Regulation (EU) 2022/2347, laying down rules for the reclassification of several active products without an intended medical purpose mentioned in MDR annex XVI.

https://criticalcatalyst.com/reclassification-of-active-products-without-intended-medical-purpose/

The transition to MDR has been slower than anticipated by the European Commission. Insufficient capacity of notified bodies and the low level of preparedness of manufacturers led to a proposal for extension of current MDR transition period with deadlines depending on the risk class of the devices.

https://criticalcatalyst.com/eu-mdr-proposal-for-extension-of-transition-period/