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The Scientific Committee on Consumer Safety (SCCS)published recently the new Opinions SCCS/1515/13, SCCS/1516/13 and SCCS/1489/12, on the risk assessment of the nano-forms of Carbon Black, Titanium Dioxide and Zinc Oxide. The aim of these Opinions is to evaluate the impact on human health of these substances when used in cosmetics.

What are nanomaterials?

Nanomaterial means an insoluble material with one or more external dimensions or an internal structure, on the scale from 1 to 100 nm.

The development of nano-cosmetic ingredients poses new challenges to their safety assessment due to the smaller size of the particles and their potential of skin penetration.

The major concern is the possibility of effects on parts of the body distant from the application site.

What are the conclusions of the SCCS?

Carbon Black (CI 77266) Titanium Dioxide (CI 77891) Zinc Oxide (CI 77947)
Function Colorant Opacifier Bulking
UV filter Skin protector
Colorant
SCCS Opinion Conclusion SCCS/1515/13Max allowed concentration as a colorant up to 10% SCCS/1516/13Max allowed concentration as UV filter in sunscreen cosmetics up to 25% SCCS/1489/12Max allowed concentration as UV filter in sunscreen cosmetics up to 25%
Limitations Decisions applicable only to the particle size, structure and purity studied
Possible eye irritations Considered not safe to use in sprays and powders Considered not safe to use in sprays
Considered not safe to use in sprays
Future Following new evidence on skin penetration the opinion will be revised

How can nanomaterials be used today in cosmetics?

  • Cosmetics containing nanomaterials have to undergo general legal obligations as the other cosmetics – they have to have a Product Information File and a compliant Safety Assessment. However, the requirements are more demanding.
  • For a nanomaterial to be used in cosmetics, all the information listed in the Article 16 of the Cosmetics Regulation has to be gathered in the Product Information File and considered for the Safety Assessment Report and submitted to the European Commission.
  • Cosmetics containing nanomaterials have to be notified to the CPNP portal six months prior to their placing on the EU market.
  • The Responsible Person performs the notification and is responsible for the compliance of the product with nanomaterials to be placed on the EU market.

What is next?

  • Publication by the European Commission of the Nanomaterials Catalogue
  • Updating of the cosmetics Regulation 1223/2009/EC Annexes with the nano forms of Carbon Black, Titanium Dioxide and Zinc Oxide. Only then these ingredients will be allowed without their specific notification to the Cosmetic Product Notification Portal indicated in article 16.

The studies performed so far are a positive sign about the safety of these nano forms but have limitations. The growing development of specific risk assessment and testing methods for nanomaterials will certainly bring new data in the near future.

Bibliography:

SCCS/1515/13 Opinion on Carbon-Black (Nano Form)

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