Recent perspectives in nanotechnology
Recent perspectives in nanotechnology
31 March 2014, 14:00 - 18:00
Chicago (Level 3, Hall A4)
This IFSCC Workshop will provide an update on nanotechnology in Cosmetics. It will focus on the requirements of the EU regulation 1223/2009/WE, enacted by the European Commission to provide tools and methodologies to measure the particle size to fulfil the nanomaterial definition, the safety studies and evaluation methods.
Organised by the IFSCC, a federation dedicated to international cooperation in cosmetic science and technology, this workshop demonstrates its aims.
Moderator: Claudie Willemin
- 14:00-14:30: Welcome and Introduction
IFSCC – What does this Acronym mean?
> Claudie Willemin, Vice President of the International Federation of the Societies of Cosmetic Chemists and President of La Société Française de Cosmétologie - SFC
- 14:30-15:15: Nanotechnology in Cosmetics - Current status in EU and Other Countries
> Dr. Florian Schellauf, Technical Regulatory Affairs- Cosmetics Europe
The legislator introduced two requirements into the EU Regulation 1223/2009 related to nanomaterials in cosmetic products.
The first requirement is the obligation to inform the consumer when nanomaterials are used in cosmetic products (“nano labelling”). The second requirement requires notification to the European Commission of cosmetic products containing certain nanomaterials. These requirements are based on the definition of a nanomaterial provided in the Regulation.
The requirements come into application from 2013 and discussions have moved from legislation to practical implementation.
This presentation will provide an overview over the use of nanomaterials in cosmetics, issues related to the implementation of the legal requirements and the interpretation of the cosmetic nanodefinition in relation to the Commission Recommendation of 18 October 2011.
Also in the international arena, there have been harmonization attempts specifically for the cosmetic sector through the ICCR process (International Cooperation on Cosmetics Regulation). ICCR defined a set of criteria for determining whether or not a material should be considered as a nanomaterial for regulatory purposes. The presentation will also provide an insight into discussions occurring around nanomaterials in cosmetics in selected countries outside of the EU.
- 15:15-15:50: Concern-driven integrated approaches to nanomaterial testing and assessment
> Dr. Robert Landsiedel, Product Safety - Experimental Toxicology and Ecology - BASF
Warranting the safety of nanotechnological products is seen as a crucial element in ensuring that the benefits of the new technology can be fully exploited. One prominent trait of NM is the fact that, during the life-time of a given NM, humans can be exposed to different forms of the material, e.g. due to agglomeration or aggregation, corona formation or interaction with surrounding organic material, or dissolution. In order to remove the need to test each form of nanomaterial in all its uses with a pre-defined, fixed list of methods, a concern-driven approach is proposed. Such approaches should start out by determining concerns, i.e. specific information needs for a given NM based on realistic exposure scenarios. Recognized concerns can be addressed in a set of tiers using standardized protocols for NM preparation and testing. Tier 1 includes determining physico-chemical properties, non-testing (e.g. structure activity relationships) and evaluating existing data. In tier 2, a limited set of in vitro and in vivo tests are performed that can either indicate that the risk of the specific concern is sufficiently known or indicate the need for further testing, including details for such testing. By effectively exploiting all available information, IATA allow accelerating the risk assessment process and reducing testing costs and animal use (in line with the 3Rs principle implemented in EU Directive 2010/63/EU). Combining material properties, exposure, biokinetics and hazard data, information gained with IATA can be used to recognize groups of NM based upon similar modes-of-action. Grouping of substances in return should form an integral part of the IATA themselves.
- 15:50-16:15: Coffee Break
- 16:15-16:50: Nanomaterials’ Safety: A Summary of the Latest Studies
> Prof. Jürgen Lademann, Center of Experimental and Applied Cutaneous Physiology, Department of Dermatology, University of Medecin - La Charité - Berlin
For more than 20 years both academic institutions and industrial enterprises have been researching into the development of strategies for drug delivery through the human skin by means of nanoparticles. However, a commercial product based on that concept is still lacking as, obviously, nanoparticles of ≥30 nm do not penetrate the human skin barrier. Whether this applies also to smaller particles is currently a topic of intense research.
First indications that nanoparticles might not penetrate the skin barrier resulted from investigations of sunscreens that contained TiO2 particles of approximately 100 nm in diameter. At the end of a 14 day test period, volunteers who had applied the sunscreen three times each day were measured for TiO2 penetration using the tape stripping method. In addition, biopsies were taken and histological sections were analyzed. The results clearly showed that the TiO2 nanoparticles were located upon the skin surface and in some of the hair follicles. The penetration profile also revealed low TiO2 concentrations near the boundary to the living epidermis. However, in follow-up investigations these TiO2 concentrations turned out to be located in the hair follicles.
Interestingly, only some of the hair follicles contained TiO2 particles. In a subsequent study it could be shown that the nanoparticles penetrated into the hair follicles only if the latter display sebum production or hair growth. This means that hair follicles are usually closed by a cover that must be opened from inside out by mass flow to permit the topically applied nanoparticles penetrating into the hair follicles. Particles of 500-800 nm in diameter were found to penetrate into the hair follicles most efficiently; either in vivo or – in the case of porcine ear model skin – if the hairs are moved by a massage. Investigating the hair surface structure, it was found that the thickness of the cuticula on the hair amounts to 600-800 nm. Due to resonance effects and if the hairs are moving, nanoparticles within this diameter range obviously penetrate into the hair follicles where they can be stored for a period exceeding 10 days. Thereafter, they escape with the sebum onto the skin surface again. A penetration of particles through the intact skin barrier could not be detected.
The problem of particulate structures, particularly of those exceeding 100 nm, is that they do not penetrate the intact skin barrier on the intercellular pathway. They remain on the skin surface and are removed by washing, textile contact and desquamation, so that scarcely any nanoparticles are detectable after 24 h. However, once the particles have been transported into the hair follicles part of them are stored there for more than 10 days and are then re-transferred to the skin surface with the sebum. In various papers nanoparticles were reported to pass the skin barrier. This is always correct if the skin barrier is disturbed. Such disturbance could have been caused by disease or mechanical manipulation, e.g., taking of biopsies, tape stripping or cyanoacrylate stripping. In such cases, nanoparticles could also be detected in the living skin. So far, no evidence has been provided to suggest that nanoparticles are capable of penetrating the intact skin. Therefore, a collaborative project was recently launched by the German Research Association (DFG) in which the excellent penetration properties of particles >100 mm shall be used to transport drugs, which would normally not penetrate into the hair follicles, efficiently to the target structures in the hair follicles where they can be released by an external trigger system.
- 16:50-17:30: Characterisation Methods for Nanomaterials for Regulatory Purposes
> Dr. Hubert Rauscher, European Commission -Joint Research Centre - Nanobiosciences Unit
Nanomaterials are addressed in the European Regulation on Cosmetic Products (EC)1223/2009 as well as in several other sectors of national and international legislation and in various guidelines. This requires clear terminology, such as a definition of the term “nanomaterial” and implementation provisions. Such a definition for regulatory purposes and its individual elements needs to be legally clear and unambiguous, and enforceable through agreed measurement techniques and procedures. The presentation highlights the technical and scientific requirements for the characterisation of nanomaterials that need to be met for this purpose and reviews currently available techniques. The contribution also offers considerations on the way forward towards the development of new measurement techniques, the combination of experimental methods and the need for validation studies for the characterisation of nanomaterials for regulatory purposes.
- 17:30-18:00: Q&A and Conclusion