CRPG Director Mohamad Mova Al'Afghani gave a presentation at the Dioxin 2018 Conference in Krakow, Poland. His presentation was based on an earlier publication: AlAfghani, MM and Paramita, D, "Regulatory Challenges in the Phasing-out of Persistent Organic Pollutants in Indonesia", the International Chemical Regulatory and Law Review 01/2018 https://doi.org/10.21552/icrl/2018/1/5

His conference presentation can be downloaded here.

CRPG's Presentation

European Commission announced that the REACH Directive will be in force in June 2007. According to the Commission in its website "The new regulatory framework will improve the protection of human health and the environment by identifying the properties of chemical substances earlier and more accurately. Particular attention is given to the most toxic properties which cause cancer, infertility in men and women, genetic mutations and birth defects. The new approach is likely to improve the innovative capability and competitiveness of the EU chemicals industry."

REACH -- after some modification -- might be applied to Nanotechnology. However, to date there has been no official announcement from the EU that REACH will govern nanoparticles and nanomaterials.

The factbook on REACH is downloadable here, the summary of the legislation is available here.

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
separately.."

The SCENIHR listed a few type of risks associated with certain circumstances:

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:

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.