Nanotechnology is an innovative area of science that includes the design, characterization, production, and application of materials, devices and systems by controlling shape and size at the nanometer scale (1–100 nm). Nanotechnology incorporation in cosmetic formulation is considered as the hottest and emerging technology available. Cosmetic manufacturers use nanoscale size ingredients to provide better UV protection, deeper skin penetration, long-lasting effects, increased color, finish quality, and many more. Micellar nanoparticles is one of the latest field applied in cosmetic products that becoming trending and widely commercialized in local and international markets.

1. Nano materials regulations in cosmetics
Presenting by
Vijayendra

2. Content
 Introduction.
 Nano system in cosmetics.
 NM used in different cosmetics.
 Nanotechnology use in cosmetics.
 General exposure considerations.
 Safety assessment of nano materials in cosmetics.
 Different regulation.
1. ICCR regulation .
2. EU regulations.
3. REACH Regulation.

3. Introduction
Bio-persistence
Multiple dimensions
Intentionally prepared molecules
Small object that behaves as whole unit
Particle size between 1nm -100nm
Different in chemical ,Physical and biological properties of larger counter parts ex: magnetic properties, altered electrical
and optical activities. these may affect Performance, safety, quality and effectiveness .

4. Nano-system used in cosmetics

5. Nanomaterials used in different products

6. Nanomaterials use in cosmetics
• Nanomaterial used as uv filters.
• Nano technology used purpose of delivery.
• Zno and Tio2 both are widely used as uv filters in cosmetics because these are
having unique functions .
a) Less greasy.
b) Less smelly.
c) More absorbable.
d) Transparent .

7. Safety assessment of nano particles in cosmetics
Physiochemical
characterizations
yes
Exposure
assessment
yes
Hazard
assessment
yes
Nano specific
safety
assessment
Is the material
nanomaterial
Is Systemic
exposure is possible
Any toxicological
effects possible?
Will the product
safe to use
no
no
Local effects
physicochemical
yes no
yes no
General
safety
assessments

8. Shape
size
Having high surface
area
Aggregate/agglome
rations
Dose metrics
General Exposure consideration
Estimating exposure for nanomaterials that deserve additional consideration. studies to estimate exposure to
nanomaterials should consider not only the chemical characteristics of the nanomaterial but also the physical form
since this can have a significant effect on absorption, distribution, and elimination kinetics due to the small size of the
materials and the tendency to form aggregates/ agglomerates. identified in a recent opinion issued under the
European REACH program RIP-oN3 (2011).
There is evidence that increased surface area may be
associated with an increase in biological activity or
toxicity.

9. Routes of exposure relevant to cosmetic use of nanomaterials
 Skin as a target organ.
 Skin as a portal of entry (EPA exposure handbook (US EPA 2011)
trade association publications such as the study conducted by the
European Cosmetic Trade Association - COLIPA (Hall, et al, 2007).
 Inhalation (droplet size is in the respirable range < 10µm.
 Oral and buccal exposure.

10. Physiochemical characterization
 OECD WPMN
 ISO (2010)
 ICCR WG (2011b
 SCENIHR (2009)
 SCCP (2007)
 EFSA (2011)
 REACH RIPoN3

11.  This guidance is specifically for cosmetic products. But it will not applicable to OTC products and other prescription
products.
 Nanomaterials are used in a variety of FDA-regulated products because of their unique properties
 In 2007 FDA has reported once document to taskforce Task Force recommended that we issue guidance describing
safety issues that manufacturers should consider to ensure that cosmetic products made with nanomaterials are safe
and not adulterated.

12. The SCCS is requested to determine the nanomaterials, as published in the recent catalogue of nanomaterials of
2019, for which specific concerns can be identified and justified in order to establish a priority list of
nanomaterials for risk assessment (Article 16(4) Reg.1223/2009)
SCCS has identified certain aspects of nanomaterials that constitute a basis for concern over safety to
consumers
o Physicochemical aspects
o Exposure aspects
o Other aspects
SCCS opinions, such as [Colloidal Silver (nano) (SCCS/1596/18), Styrene/Acrylates copolymer (nano) + Sodium
styrene/Acrylates copolymer (nano) (SCCS/1595/18) and Silica, Hydrated Silica, and Silica Surface Modified
with Alkyl Silylates (nano form) (SCCS/1545/15)], the SCCS is requested to assess if a potential risk can be
identified according to Article 16(6) Reg. 1223/2009.
SCCS guidance on nanomaterial

13. Article 16 (1) For every cosmetic product that contains nanomaterials, a high level of protection of human health
shall be ensured.
Article 16(2) The provisions of this Article do not apply to nanomaterials used as colorants, UV-filters or
preservatives regulated under Article 14, unless expressly specified.
Article 16(3) In addition to the notification under Article 13, cosmetic products containing nanomaterials shall be
notified to the Commission by the responsible person by electronic means six months prior to being placed on the
market, except where they have already been placed on the market by the same responsible person before
11 January 2013
Article 16(6) Taking into account the opinion of the SCCS, and where there is a potential risk to
human health, including when there is insufficient data, the Commission may amend Annexes II
and III
Provisions EU commission

14.  Cosmetics placed on the EU market are regulated by the Regulation on cosmetic
products. It provides a safety framework and established a central notification
system for cosmetic products placed on the EU market
 Manufacturers, importers or their appointed third parties need to register their cosmetics via
the Cosmetic Products Notification Portal (CPNP). If a product contains nanomaterials, the
notifier needs to identify the nanomaterial and specify the likely route through which a person
may be exposed to it.
 Colorants, preservatives and UV filters must be
authorized by the EC prior to their use in
cosmetics. Before authorization, the Scientific
Committee on Consumer Safety (SCCS) reviews
the toxicological data related to the substance for
which the authorization is sought. (Link)
REACH Regulations

15. References
1.INTERNATIONAL COOPERATION ON COSMETICS REGULATION (Link)
2.ECHA-European union observatory for nanomaterials (Link)
3. GUIDANCE ON THE SAFETY ASSESSMENT OF NANOMATERIALS IN COSMETIC (Link)
4. New Insights on Unique Features and Role of Nanostructured Materials in Cosmetics (Link)
5. REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL (Link)