Showing posts with label labelling. Show all posts
Showing posts with label labelling. Show all posts
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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.

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EU-US regulatory gap?

Sunday, December 3, 2006

Recent WTO panel ruled out that the GMO moratorium conducted by the EU is illegal. The panel stated that EC safeguard measures "were not based on risk assessments satisfying the definition of the SPS Agreement and hence could be presumed to be maintained without sufficient scientific evidence." This is what the european commission said about the GMO case:
The US appears not to like the EU authorisation regime, which it considers to be too stringent, simply becaue it takes longer to approve a GMO in Europe than in the US. The US appears to believe that GMOs that are considered to be safe in the US should be de facto deemed to be safe for the rest of the world. The EU has argued that a sovereign body like the EU and its Member States, or indeed any country in the world, has the right to enact its own regulations on the food that its citizens would eat, providing that the measures are compatible with existing international rules and based on clear scientific evidence.The US also opposes GMO traceability rules because it considers that they constitute an obstacle to US commodity exports, despite the fact that US traders can in fact meet those requirements without difficulties. The US is also adamantly opposed to labelling rules for food products produced from GMOs, even though these rules are designed to help ensure that customers are well-informed about what they are buying.
This case is a lesson for future nanotech regulation. Thus, it would be important to consider (i) how stringent the regulations would be (ii) what examination standard to be used, (iii) how labelling are to be applied.

My previous post indicates that most people in Germany wants labelling, especially when it comes to the utilisation of nano in food industry. There will be a problem when the US impose lower labelling standard compared to EU, or vice versa.

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Consumer demand labelling

That was the result of a Conference held by the German's Federal Institute of Risk Assessement:
Our experience shows that an event of this kind is well suited to involving consumers in the scientific debate about the assessment of new technologies. When making their judgement, consumers took a very differentiated look at the potential risks and benefits of nanotechnology based on knowledge of the latest research and the existing uncertainty.
According to the conference, consumers were especially critical of the use of nanomaterials in foods.

With regards to the weighing between risk and benefit, consumer tends to put more weight on the risk nanotech brings, in comparison to its benefits:
Consumers felt that the promised advantages to be derived from using nanotechnology like changes to the flow properties of ketchup or the trickling properties of products were non-essential given the potential risks.