Filed under: Cosmetics, EU Information, Nanomaterials | Tags: Cosmetics, nanotechnology, toxicity testing
The European Commission has asked for more detailed toxicity data on three nano ingredients which are quite commonly used in cosmetics.
The three substances are:
- nano collodial silver;
- nano styrene/acrylates copolymer; and
- nano sodium styrene/acrylates copolymer.
Nano colloidal silver is used as an antimicrobial, has a lowest cut off particle size of 1 nm and a maximum concentration up to 1.0 % in cosmetic products. Although the toxicity data needs to be more detailed, there is still a difficulty in accurately characterising and measuring the concentration of nano-colloidal silver, with robust validated methods not being available.
Similar problems exist for the nano-forms of the two copolymers.
Filed under: ECHA, EU Information, Nanomaterials | Tags: measurements, nanotechnology, REACH
The presentations given at a nanomaterials workshop held at the ECHA premises in Helsinki in October 2014 are now available on the ECHA website. The workshop, “Regulatory Challenges in Risk Assessment of Nanomaterials” covered a range of topics, with a wide range of speakers and delegates attending. One of the themes which emerged from the workshop was that of the need for measurement strategies to be able to identify nanomaterials according to the proposed EU definition: a material with 50 % or more of particles, by number size distribution, having a size between 1 nm-100 nm. This is needed before risk assessments can be carried out, so we know we are dealing with nanoscale materials specifically.
Some information was presented on methods for characterising and measuring nanoparticles which had been carried out under the EU Framework Programme 7 NanoReg 2 project.
It is encouraging to see that work is progressing towards metrologically-sound methods being developed for characterisation and measurement of nanomaterials, and that attention is being paid to the practical aspects of defining nanomaterials as part of the overall risk assessment and regulatory process.
Filed under: EU Information, EU Regulation/Legislation, Nanomaterials | Tags: measurements, nanotechnology, regulation
The European Commission has stated that it will be unable to meet its self-imposed deadline of December 2014 for agreeing an EU definition of what constitutes a nanomaterial. This was announced at a symposium organised by the Nanotechnologies Industries Association (NIA) in Brussels recently.
The Commission are waiting for the third instalment of a report from their Joint Research Centre laboratory which will cover technical and scientific recommendations that should be taken into account in the review of the nanomaterial definition. This report is not available yet, and it is important to wait until it has been published. This blog has long considered that it is essential that any definition of a nanomaterial must be supported by validated measurement methods which can accurately enforce such a definition.
The Commission intend that the definition should apply across different sector-specific pieces of legislation, where nanomaterials are considered. This is to be supported, as the fragmentation of some EU regulation, with different rules in different sectors is something that should ideally be avoided.
It is hoped the definition will be agreed during the first half of 2015.
Filed under: Environment/Ecology, EU Research, Nanomaterials | Tags: Environmental, nanotechnology, testing
The European Commission has published a report in their Science For Environment News Alert, which highlights the concern over the fate of nanoparticulate silver (nano-silver) which is released into the aquatic environment. Nano-silver is used very effectively as a bactericide in many clothing products, particularly socks. They are considered to be anti-microbials, in that they release silver ions which inhibit bacterial and microbial growth.
However, it is this very behaviour which has prompted this concern. The propensity of nano-silver to release ionic silver is damaging to the environment as it is now widely thought that ionic silver is significantly more toxic to the aquatic environment than uncharged nanoparticles of silver.
In order to gain a more robust assessment of the environmental threat from silver, researchers do need to be able to measure levels of both charged ionic silver, and uncharged nano-silver. Measuring total silver will not enable ecotoxicologists to obtain an accurate picture of the ionic silver load to the environment. Differentiating between the two forms is essential, therefore, and we believe that work should be undertaken to achieve this; we do not believe that this task is impossible. Work should commence within LGC on this in the near future.
Filed under: EU Information, Nanomaterials | Tags: nanotechnology, Reference Materials
The world’s first certified reference material (CRM) of a nano-substance has been developed and released to the market by the Institute of Reference Materials and Measurements (IRMM) of the European Commission’s Joint Research Centre in Geel, Belgium.
The material, which consist of two distinct silica nanoparticle groups, with nominal particle sizes of 20nm and 80nm diameter (ERM®-FD102) allows testing laboratories to validate particle sizing methods in a metrologically sound manner in the nanoscale range (1 nm to 100 nm). It has been characterised using a range of techniques including dynamic light scattering, atomic force microscopy, electron microscopy, particle tracking analysis and centrifugal liquid sedimentation.
This marks a significant breakthrough in our metrological measurement capability needed to underpin the EU’s definition of a nanomaterial, which is due to published in its final form in early 2015. It is not possible to properly regulate this important new branch of the chemical industry without appropriate validated methods to ascertain what is and what is not a nanomaterial, and this CRM is a very important step on this path.
The national competent authorities for REACH and CLP (Caracal) has extended the mandate of its sub-group on nanomaterials (CASG Nano) for a further 18 months, through to June 2016.
Two of the very important areas for which the group is responsible, within the frame of REACH, are:
- Substance identification
- Definition of a nanomaterial
These are clearly issues with a very significant measurement dimension, and work needs to be undertaken to ensure that the EU has validated methods for identifying, characterising and quantifying nanomaterials, which can support an agreed, practical, definition of a nanomaterial.
Filed under: EU Information, Nanomaterials | Tags: measurements, nanotechnology
The European Union’s Joint Research Centre (JRC) had published a new report “Towards a review of the EC Recommendation for a definition of the term “nanomaterial”: Part 2: Assessment of collected information concerning the experience with the definition”, which highlights the debate surrounding the proposed EU definition of a nanomaterial, which has been highlighted previously on this blog. It follows on from an earlier report which collated information surrounding the definition and potential enforcement and monitoring tools.
The problems associated with the proposed definition of a nanoparticle – 50% of particles in a population must have one dimension in the range 1nm to 100nm – have always been the lack of validated methods which laboratories can use in order to monitor this. Indeed, introducing a draft definition with no associated measurement methods, compounded by the introduction of nanomaterial registers in some EU Member States, is really doing things back to front.
The concern about analytical measurement methods – and the report also highlights the difficulties in determining the uncertainty of nanoparticle measurements – also leads the authors to a conclusion that analytical techniques may not be capable of assessing whether over 50% of particles fit within the size limits. This leads them to pose the question as to whether the definition would be easier to monitor if the 50% limit were to be based upon mass fraction rather than number of particles. This would certainly be an improvement and, as nobody really wants a definition enshrined in EU law that can not be monitored or enforced, should be given very serious consideration.
The report also addresses the thorny issue of aggregated and agglomerated particles, and the difficulty of counting particles which have aggregated. It is to be hoped that the excellent and practical recommendations made in this report are taken on board in Brussels before the final nanoparticle definition is agreed and published.