, , , , , , , ,

REACH is not enough, new labelling method might be required

Monday, December 4, 2006

Scientific Committee on Emerging and Newly-Identified Health Risks (SCENIHR) is one of the three independent scientific committes managed by the EU's directorate general of health and consumer protection. Its task is in giving considerations and insights into "where amendments are needed to procedures for assessing risk of the products of nanotechnologies, and identifies areas where major gaps in knowledge exist."

The EU Comission launched a public consultation in December 2005 and published its recommendations based on the consultation:

With regards to Hazard Evaluation, "The SCENIHR opinion highlights that the paradigm for nanotoxicology does not exist and there is a need for a case-by-case assessment of environmental and health impacts of nanotechnology products" and consider it beneficial to "bench mark studies, including reference materials with very well understood toxicology in man, such as quartz and asbestos."

In its report, it acknowledges that "Due to the lack of available data on the risk characterisation of different nanoparticle-based products, no generic conclusions are possible at this stage.
Consequently, each product and process that involves nanoparticles must be considered

The SCENIHR listed a few type of risks associated with certain circumstances:
  • Worker safety during the manufacture of nanoparticles.
  • Safety of consumers using products that contain nanoparticles.
  • Safety of local populations due to chronic or acute release of nanoparticles from manufacturing and /or processing facilities.
  • The impact on the various environmental compartments per se resulting from production, formulation and use, and on the potential for human re-exposure through the environment.
  • The environmental and human health risks involved in the disposal or recycling of nanoparticle dependant products.
These characterisation by the SCENIHR reflects the possibility of regulating nanotechnology in each economic chains, from production, to consumption, to dumping, to the re-usage. If this is adopted, then the future EU regulation will comprise of a process-focus regulation, product-focused regulation and sectoral regulations.

The SCENIHR also suggest a precautionary approach with respect to "nanoparticles which are likely to be highly biopersistent in humans and/or in environmental species." It also stresses that "there is no reliable information on the effect of the simultaneous exposure to multiple forms of nanoparticles, where it would be appropriate to assume the effects are additive, or on the interaction between nanoparticles and other stressors (either physical, chemical or biological), which should be considered on a case-by-case basis."

Nanoparticle as stressor is particularly important as it means that a hazardous effect may not be resulted not from the nanoparticle itself but due to its surroundings. This means that each producer of nanoproduct will have the obligation to dilligently provide information on how consumer should treat their product. Possible allergic reaction should also be provided and this may not be an easy task. In my opinion, this will carry several legal consequences:
  1. There has to be a regulation on the storage and transportation of nanoproducts which contain hazardous nanoparticle
  2. Some nanoproducts shall not be sold for free
  3. Producer can be exempted from liability if they can prove that they have provided adequate information on how a product should be treated
It is interesting to note that the SCENIHR regards the current REACH proposal may be inadequate:
The regulation of products containing nanoparticles based on tonnage, as proposed for existing chemicals under REACH, needs to be considered further because there are many more nanoparticles to the tonne than is the case for larger particles, and their behaviour in the body and in the environment may be different. If the nanoparticle form of a chemical does have distinctly different properties in biological systems from other physical forms of the same chemical, it will be necessary to readily identify the nanoparticle form of each chemical for the purposes of hazard warning labels etc. One approach to ensure that the effects of the nanoparticle form of a chemical is properly assessed would be to have a unique identification for it, either assigning different CAS numbers to the nanoparticle form, or adding a code (CAS-NP50) to existing CAS numbers leaving the CAS number for identifying similar chemical compounds . It is also inappropriate to assume that current workplace exposure standards for dusts can be applied directly to the nanoparticle form of the dust component. New standards will therefore need to be considered. Similarly, classification and labelling for human health and the environment may need to be reconsidered.
This point is especially important. This suggest that nanoproduct shall not and cannot be treated as chemicals, because their properties are different from chemical bulk. A legal consequences of this is that, producers cannot rely merely on REACH in conducting their safety standard as their duty to care with regards to nanoproduct is different than those established under the REACH. Another important thing is: there is going to be another classification/labelling method for nanoparticles that is different from normal chemical classifications.

You can download the complete report here, and the summary here.

Email me for suggestions, or leave a comment.