NANOPARTICLES

Date: 10th January 2011

POSITION PAPER

NANOPARTICLES

Prepared by John Staton Dermatest Pty Ltd

Executive Summary.

1.The ASCC is of the opinion that the balance of scientific evidence is that there is no reason for concern for users of personal care and cosmetic products.

2. ASCC has the position that there is no current scientific evidence to support the discrimination of these forms of cosmetic ingredients from other grades of the same chemical substance.

3. ASCC recognizes the value of nanotechnology in the improvement of the efficacy of inorganic materials, particularly those used in sunscreens.

4. ASCC recognizes the importance of protecting employees in the industry from incidental ingestion or inhalation of these materials during the fabrication of cosmetic and personal care products.

5. ASCC recognizes that some imported cosmetic products will shortly be displaying a “nano” identifier for relevant chemicals listed on ingredient label declarations.

What are Nano-particles?
NICNAS (1) has defined nanomaterials as “… industrial materials intentionally produced, manufactured or engineered to have specific properties or specific composition, and one or more dimensions typically between 1 and 100nm.”

The European Union (2) has recently determined that " 'nanomaterial' means an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100nm" Currently, a Scientific Committee of the E.U is reviewing definitions as they relate to regulatory interpretations(3) and this definition may be modified.

What is the status with Australian and Overseas Regulatory Bodies?

NICNAS: The Nanotechnology Advisory Group (NAG) (4) has recommended to NICNAS that the issue be addressed and has proposed reforms to the Industrial Chemical (Notification and Assessment) Act 1989. (5)
The key elements of NICNAS's proposals are to exclude 'novel' materials in the nano-size range from low-volume exemptions that exist under NICNAS regulatory rules and to consider many existing chemical ingredients that could be available either now or in the future in nano-form; e.g. silver as nano-silver or gold as nano-gold.

TGA : According to the recent determination of Therapeutic Goods Administration of the Aust Dept of Heath and Ageing, in its review in 2009 (6), “Currently, there is no in vivo evidence to indicate possible toxicity of nanoparticulate TiO2 or ZnO in people using sunscreens. To date, the current weight of evidence indicates the particles remain on the surface of the skin and in the outer dead layer (stratum corneum) of the skin”.

USA : Under the Toxic Substances Control Act, many nanomaterials are regarded as "chemical substances" under the Toxic Substances Control Act (TSCA) (8). This law provides EPA with a strong framework for ensuring that new and existing chemical substances are manufactured and used in a manner that protects against unreasonable risks to human health and the environment.

The FDA has stated that it recognizes that an increasing number of sunscreens containing small particle size Titanium dioxide and Zinc Oxide enter the US market every year and had sought submissions, which are currently under consideration.

ISO TC 217 Cosmetics has begun the process of considering such materials as they relate to cosmetics. This is being approached in co-ordination with the E.N. and other Working Groups of ISO, where a number of documents related to the nano field are under development. (9) (10).

Putting Nano in Perspective.
Nano-particles are not new and have always been “naturally” present in the environment, for example, in dust, motor vehicle fumes, cigarette smoke and where-ever a dry powdered material is crushed for some process.

The current concerns relate to the intentional processing of materials so as to produce uniformly low size solid materials.

Where do they appear in cosmetics and personal care products?
The major use of intentionally manufactured nano-particle materials is in the preparation of some sunscreen products. Typically, these are Zinc Oxide and Titanium Dioxide. The benefit of the use of nano grades is that they provide very high efficacy (increasing SPF and UVA protection) whilst reducing the grey paint effect of these inorganic actives, thus providing better cosmetic elegance as well as improved health effects.

It should be noted that, although the zinc oxide or titanium dioxide is very fine, in many sunscreens these are used in a pre-coated form which already lifts the ingredient out of the nano size. Many products now contain grades of these materials, which have a particle size already above the nano level.

Occasionally other types of cosmetic products include nanomaterials, but these are in a small minority.

A certain number of nano size particles can unintentionally be produced when any powdered material is ground.

What are the concerns?
The concerns for nanomaterials fall into two basic categories. …
Firstly, there is a theoretical possibility that particles of such a small size could be absorbed through the skin or other body organs.

Secondly, the handling of these as raw materials when in their uncompounded form needs to take into account the potential for ingestion or inhalation.

Whilst the toxicological profile of these materials is well known, the essential concern is that there may be unknown consequences for human health for as yet unidentified adverse effects from the use of such small particles of these already known and mostly widely used materials.

What have others recommended?

TGA:
(11) “TGA does not require any specific warnings about nanoparticles to be placed on labels of sunscreens. To date, mandatory labelling of nanoparticles in sunscreens has not been introduced anywhere in the world.”

NICNAS: The outcome of discussions with industry and other interest groups are expected to appear later in 2010.

E. U. (12) have actioned the new rules regarding labelling “All ingredients present in the form of nanomaterials shall be clearly indicated in the list of ingredients. The list of such ingredients shall be followed by the word 'nano' in brackets." This will come into force in 2013.

FDA: At the time of this review, FDA are still to bring down their determination regarding the relevance for sunscreen product actives and this review will form part of the Final Ruling for sunscreen products when this is finally brought down.

ASCC Position
The ASCC is of the opinion that the balance of scientific evidence is that there is no reason for concern for users of personal care and cosmetic products.

With the adoption of the “nano” suffix system in the E.U., there will be pressures from both the marketing and the consumer fronts to adopt the same marking system for Australia.

In relation to handling of cosmetic ingredients during manufacture, the appropriate procedures for occupational health and safety already in place in the industry should be applied in the same way as they apply for the handling of all fine powders.


References

1. Proposal for the Regulatory Reform of Industrial Nanomaterial Australian Government Dept of Health and Ageing NICNAS National Industrial Chemicals Notification and Assessment Scheme Public Discussion Paper Nov 2009
http://www.nicnas.gov.au/Current_Issues/Nanotechnology/Consultation%20Papers/NICNAS_Nano_PUBLIC_DISCUSSION_PAPER_PDF.pdf

2. Cosmetics Containing Nanomaterials European Commission Dec 2009
http://ec.europa.eu/enterprise/sectors/cosmetics/cosmetic-products/nanomaterials/index_en.htm - h2-what-are-the-rules-in-europe-for-the-use-of-insoluble-nanoparticles-in-cosmetics?

3. Scientific Basis for the Definition of the Term “Nanomaterial”
ec.europa.eu/health/scientific_committees/emerging/.../scenihr_o_030.pdf

4. Nanotechnology Advisory Group http://www.nicnas.gov.au/Current_Issues/Nanotechnology/Nanotechnology_Advisory_Group.asp

5. Industrial Chemical (Notification and Assessment) Act 1989.
http://www.austlii.edu.au/au/legis/cth/consol_act/icaaa1989465/

6. A review of the scientific literature on the safety of nanoparticulate titanium dioxide and zinc oxide in sunscreens. Australian Government Dept of Health and Ageing Therapeutic Goods Administration OTC Medicines Section July 2009
http://www.tga.gov.au/npmeds/sunscreen-zotd.pdf

7. Nanotechnology under the Toxic Substances Control Act US Environmental Protection Agency
http://www.epa.gov/oppt/nano/

8. Federal Register Vol 72 No 165 Monday Aug 27 p 49110
http://edocket.access.gpo.gov/2007/pdf/07-4131.pdf

9. ISO/TC 229/WG 4 N 053 Nanotechnologies — Nanoscale titanium dioxide (powdered form) — Part 1:Characteristics and measurement

10. ISO/TC 229/WG 4 N Nanotechnologies —Nanoscale titanium dioxide (powdered form) — Part 2: Specifications for sunscreen application

11. TGA Sunscreen Factsheet Aug 2009
http://www.tga.gov.au/npmeds/sunscreen-zotd.htm

12. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. Official Journal of the European Union L 342/59.

http://www.google.com.au/search?hl=en&source=hp&q=REGULATION+%28EC%29+No+1223%2F2009+OF+THE+EUROPEAN+PARLIAMENT+AND+OF+THE+COUNCIL&btnG=Google+Search&meta=&aq=f&oq=

Reviewed Date 5th Aug 2010