11 Changes to SCCS Guides for Cosmetics Safety Testing — Plus a Note on 'Nano'

Dec 15, 2023

The EU's Scientific Committee on Consumer Safety (SCCS) recently released the 12th revision to its Notes of Guidance (NoG) for cosmetics and cosmetic ingredient testing; the previous revision to the NoGs took place in 2021. Per the SCCS, the NoGs are designed to direct public authorities and the cosmetic industry in order to improve harmonized compliance with the current cosmetic EU legislation.

The guides are regularly revised to incorporate the progress of scientific knowledge in general and the experience gained particularly in the field of testing and safety evaluation of cosmetic ingredients. While the guides are focused on cosmetic ingredients, some indirect guidance is given for the safety assessment of finishedproducts as well.

Cosmeticlegislation Regulation (EC) No. 1223/2009 was fully implemented in recent years, banning animal testing for cosmetics. As such, the SCCS reports it has closely followed the development and validation of alternative testing methods with an emphasis on replacement methodologies.

See related: After 8+ Years, is Canada Ready to Ban Animal Testing for Cosmetics?

Changes to the NoGs focus not on only on animal testing alternatives, but also consider exposure data and testing, sun protection, CMRs, endocrine disruptors and more. The following is an overview of the 11 main changes; additional details are provided in the full 203-page document.

In relation in its Nano and Other Emerging Chemical Technologies blog, legal firm JD Supra highlighted the 12th revision changes to the NoGs pertaining to nanomaterials as follows:

Nanomaterial = intentionally produced: Per Article 2(1)(k) of the Cosmetic Regulation, nanomaterial means "an insoluble or bio-persistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm." The blog underscores that according to the NoGs, "[t]he Regulation therefore mainly covers those nanomaterials that are intentionally produced and are insoluble/poorly soluble or biopersistent (e.g., metals, metal oxides, carbon materials, etc.), and not those that are either completely soluble or degraded and are not persistent in biological systems (e.g., liposomes, oil/water emulsions, etc.)."

Testing nanomaterials: Also per the NoGs, "In general, a number of reviews have concluded that the existing risk assessment paradigm, in use for conventional chemicals, should in principle be also applicable to engineered nanomaterials. However, it has also been pointed out that the current testing methods may need certain adaptations to take account of the special features of nanomaterials."

Nanomaterial information requirements: Finally, in addition to safety data on the core nanomaterial, the SCCS would also minimally require: