Showing posts with label eu. Show all posts
Showing posts with label eu. Show all posts
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“Obstruction of performance” under Article 86(2) of the EC Treaty and its application to the water sector

Thursday, January 15, 2009

My master thesis attempts to define "Obstruction of performance" under Article 86(2) of the EC Treaty and how this category can be applied to the water industry. The thesis argued that Obstruction of performance has to be narrowly interpreted and necessity/proportionality of the measure has to be taken into account in order to invoke "Services of General Economic Interest" (SGEI) justification under the EC Treaty. Comparing with electricity and gas sector, I conclude that specific situations in the water industry may justify its exclusion from general EC Competition rule. Scenarios where "obstruction" in the water industry occurs were explored.

Preiview:
Provision of water and sewerage services has traditionally lies upon the responsibilty of the state for ages. Internal market integration and liberalisation processes so far had always exclude water sector from its agenda. Even until today, there has been no sectoral regulation adopted by the EU concerning liberalisation of water and sewerage services. The Parliament in its Resolution makes clear of its position that it rejects water being put in a sectoral directive due to its regional characteristics, but calls for “…without going as far as liberalisation, for water supply to be ‘modernised' with economic principles in accordance with quality and environment standards and the needs of efficiency”.

However, the Comission had shown its interest in liberalising water and sewerage service. The annual turnover of the water sector in EU is estimated at 80 billion Euro, more than the turnover of the gas sector. The Commission has expressed concerns that horizontal and vertical restrictions from long term supply dealings “…may be harmful and contrary to EC law even where national law allows them”. In its internal market strategy for 2003-2006, water is listed as one of the area where” new action may be required”, by reviewing legal and administrative situation in the water and waste-water sector, which include an analysis of the competition aspects.

Download the full thesis here.

 

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Regulating Nanotechnology Wihtin Precautionary Principle

Tuesday, July 17, 2007

A Report from the Institut fuer oekologische Wirtschaftsforschung for the European Parliament benchmarked precutionary principle embodied in several environmental legislations, from the REACH in EU to TSCA in the US.

From the report, you can tell which side of the world advocates stronger precautionary principle and how it affects future nanotechnology regulation. Read the report here.

 

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EU sanction on Indonesian airlines -- some legal obligations

Thursday, June 28, 2007

I forgot to mention one legal obligation that can be derived from the sanction: a travel agent operating in EU territory would be obliged to inform the passengers if they are booking non-favoured airlines.

Imagine what the effect would be for Indonesian tourism industry.

 

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EU's "incrimental approach" in regulating nanomaterials

We've had discussions on the Berkeley's regulation and I have posted some articles on EU's REACH. Here's an article explaining existing EU's regulatory infrastructure applicable to nanomaterials/nanoparticles and its weaknesses:
The European Commission has adopted a so-called ‘‘incremental approach’’, which focuses on adapting existing laws to regulate nanotechnologies, and therefore this paper aims to test the effectiveness of the ‘‘incremental approach’’. Three commercially available products containing fullerenes (C60 and carbon nanotubes) were analysed in a life cycle perspective in order to (1) map current applicable regulations, (2) analyse their applicability to nanomaterials, (3) identify their gaps, and (4) suggest proper solutions.
Read the full paper here.

My general observation: the paper still based itself on "emission" paradigm. Thus, the playing field is in the lowering of permissible emission. An important point here is that the paper suggested "free nanoparticles" to be exclusively categorized under the REACH and that it should be specifically registered. Interestingly, the paper recommends bottom-up nanoparticle to be regarded as "new substance".

 

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Indonesian airlines 'punished' by the EU

European Union is a standard-freak, we all know that. They regulate everything from the amount of detergents allowed to be spilled into sewerage to the position of labels in wine bottles. These regulations are good, they ensure safety and consumer protection, for EU citizens.

But hey, the EU also has a substantial "market power", they can also regulate foreign private parties to comply with their laws. If you want to land on our airports, make sure you comply with our safety standards, otherwise, get the hell outta here. Nice:
All Indonesian airlines including national carrier Garuda are to be banned from the European Union. "European citizens should avoid flying with these carriers," an EU official said. "They are really unsafe."

The new list, decided upon following advice from an EU air safety committee, is expected to be formalised within a week. Garuda flew to Rome and Amsterdam until 2005, and is planning to resume services to Amsterdam in 2008.

The idea or regulating things based on territoriality is normal. But look also at the indirect effect of this regulation: warning people not to take Indonesian airlines, because they are unsafe. Now that's a market power!


 

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Precautionary Principle Urged (Again?)

Friday, June 15, 2007

A news from the EU (but it turned out to be not so new):
"Current scientific risk-assessment methods [for nanomaterials] are really not reliable. We don't have the knowledge. Nanomaterials are so small and reactive and we don't have natural defences in the body against them," said Eva Hellsten, from the Commission's DG Environment, Directorate Water, Chemicals and Cohesion.
EU are still debating as to whether nanomaterials/nanoparticles would be sufficiently regulated in its REACH directive. To sum up, their position on regulating engineered nanoparticles remans the same:
1. IS REACH enough or not?
2. We don't have "sufficent knowledge"
3. More money required for research
4. Precautionary Principle vs 'non' Precautionary Principle

So in this part of nanotech regulation, there is really nothing new in any part of the world. Boring!

 

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Europe entering the 'Internet of Things'

Sunday, March 18, 2007

I will go to Hannover to attend this year's CeBIT. And guess what I really plan to see: RFID stands!

I want to know what the latest RFID gadget can do and how the tech will affect regulation. The European Union has just recently unveiled its future RFID strategy and policies:
The Commission, in particular, proposes to address the privacy concerns of citizens to boost consumer confidence and Europe's position in a market experiencing 60% growth globally.
RFID Law is just beginning to evolve. Its orbit: health and environmental issues, freqency allocation and, our favourite subject, the internet of things. The EU's COM stated:
In the responses to the online questionnaire, 86% of respondents were concerned that the system for registering and naming of identities in the future "Internet of Things" should be interoperable, open and non-discriminatory.
Oh, in case you are not yet informed what internet of things means, it means that we can virtually hyperlink anything we have in the real world to the internet and locate them. That way I won't lose my keys anymore. If you want a start up info on this subject wikipedia is glad to help.

If you will be in Hannover on March 21st (that's, the last day of CeBIT), email me!

 

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European Union plans to open representative in Secondlife

Friday, March 9, 2007

I like the EU for its legal promulgation method. They always put everything on the net to be published and discussed. Now, they plan to open representative in Secondlife. Wew...
The European Union is looking into entering the virtual world and opening up an office in Second Life - an increasingly popular internet-based virtual world - which the Swedish government and the French presidential candidates have already entered. "It is certainly an idea we are looking into," commission spokesman Mikolaj Dowgielewicz told EUobserver.

Sweden had opened their embassy there. Dunno if we can apply visa there tho...

 

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EU perspective on Nanomedicine

Friday, February 2, 2007

Olivier Van Droogenbroek referred me to the latest EGE (European Groups on Ethics in Science and New Technologies) activity: its adoption of the 21 st Opinion on the ethical aspects of Nanomedicine. The document is downloadable here.

Here's an excerpt on what they think, the hardest challenge to laws and regulations will be:
  1. the risk evaluation for nanomedicine may not be adequate in all areas;
  2. the implementation of risk evaluation measures should be carried out in a scientifically sound and transparent manner;
  3. there is a need for legal clarity in a number of areas especially where regulations and/or areas overlap;
  4. ethical dimensions must be taken into account in legal provisions
  5. on nanomedicine.
I have not look this document throughly. I found however, some interesting remarks on human enhancement, intellectual property and data protection as a result of the use of nanomedicine.

I will discuss the topics more detail in my later posts.

(H.T. Olivier Van Droogenbroek)

 

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Nanotechnology Regulation in EU

Wednesday, January 17, 2007

Prof. Van Calster's article for NLB on european nanotechnology regulation is available for download at Nanoforum's website here (free signup required). Here's a quote:
The expectation is that the EU will adopt a cautious approach, following the example of the European Chemicals policy under REACH. In that case, the burden of proof of safety is shifted from the authorities to the manufacturer. Product liability law is less likely to be applied, because this area is not harmonised at EU level. Geert van Calster compares the EU and US legislative framework and trends.

 

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REACH directive in force this June

Sunday, January 7, 2007

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.

 

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Regulating nanotech in food packaging

Wednesday, January 3, 2007

Nanologue has completed its interview research conducted at the sponsorship of the EU. This post will highlight the part of the research discussing regulaiton of nanotech in food packaging.

According to the research, nanotech in food packaging will bring benefits in the form of (i) Reduced usage of energy and raw materials (polymers) (ii) improvement of the mechanical properties of biodegradable polymers (iii) beneficial for reusable packaging due to improved mechanical strength and (iv) help to reduce the amount of packaging waste and save resources at the same time. There are however, risks associated with this. The first type of the risk deals with inconclusive research on impacts and lack of effects data: (i) Knoweldge about the effects of engineered nano-materials in the environment is still insufficient (ii) Risk of environmental pollution by nanoparticles (persistence and unknown catalytic effects) whereas the rests of the risks are common risks also found in normal chemicals which relates to pollution and waste: (a) Release of nano particles into the environment during the production and disposal phases of a product, (b) Uncontrolled incineration of nanocomposites could cause emissions of nanoparticles into environment and (c) Nanocomposite materials could disturb plastic recycling processes. Recyclers will have to deal with nanoparticular fillers, which eventually will be found in recycled materials.

Now, let's compare this with FDA's institutional capacity as has been discussed in my previous post. Taylor divided supervision mechanisms (on food packaging and other products) into pre marketing and post marketing.

Pre marketing. He reported that FDA's authority to inspect product on the pipeline is 'weak'. However, it has the strong capacity to (i) enforce safety and testing requirements, (ii) place burden to prove safety to sponsor and (ii) review safety prior to marketing. Post marketing. FDA has only moderate capacity to inspect facilities and safety records and it has 'no' capacity to requiry timely adverse event reporting or in requiring producers to conduct post market monitoring and testing. It has however, strong authority to remove unsafe products from the market -- of course!

The Nanologue's concerns with regards to "food packaging" is more toward its environmental risks (I suppose it means the use of nano-bags in replace of paper bags) while Taylor's report concerns more to its health impact. I think the nanologue should have also highlighted more on the implications of nano-food packaging to human, although food packaging undeniably have important side-effect towards the environment. When it comes to Taylor's proposal, then the recommendation is relatively simple: move the gradation of FDA's authority from 'none' or 'moderate' to 'strong'. This can provide a good balancing when a weaker precautionary approach is selected.

In my next post, I will try to highlight the regulation of nano-food packaging in the European Union. Meanwhile, you can read Nanologue's report here.

 

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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
separately.."

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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European Nanotechnology Law?

Friday, December 1, 2006

A few days ago the European Parliament issued an action plan on Nanoscience and Nanotechnologies. This action plan is not legally binding and is deemed simply as a declaration of intention in regulating nanotechnology further. In general, there is nothing special under the action plan as it only stresses on the importance of research and impact assessments. There are, however, some paragraphs that reflects the position of the European Union with regards to nanoscience and nanotechnologies.

For example, the action plan:
  • Recommends that lists of ingredients in consumer products identify the addition of manufactured nanoparticulate material;
  • Regrets the fact that the patenting of nanoscience and nanotechnology inventions in Europe is developing slowly; calls on the EU to create a nanoscience and nanotechnology patent monitoring system governed by the European Patent Office;
  • Encourages general reforms in the field of the European patent system in order to cut the costs of patenting and to improve accessibility to patents for SMEs; stresses the need for greater transparency and clear limits to the scope of patent protection;
  • Emphasises the need to respect high ethical principles and welcomes the planned reviews on issues such as non-therapeutic human enhancement and links between nanosciences and nanotechnologies and individual privacy; expects the reviews to be public and to include a thorough analysis of nanomedicine;
The above points suggests the EU position toward labelling and patent reform. The last point on human enhancement is especially important and this shows EU's high awareness on the interconnectedness between human enhancement and nanotechnologies. You can compare it with UNESCO's view on human enhancement here.

Currently, the status of european nanotechnology regulation is more or less equal to the US': There are no specific law regulating it. It is questionable whether existing regulations in the field of environmental (such as the REACH proposal), health, workplace and food and drugs can directly apply to nanotechnology, due to differences of characters. There are suggestions to put nanotechnology under the REACH proposal but there are also worries that it may not be able to cover "finished product" such as a transistor.

Nevertheless, there are general environmental regulations under EU auspices which applies to every risky activities, including nanotechnologies. The factories, laboratories and storing facilities of nanoproducts could be subjected to environmental impact assessment directive 85/337/EEC, or IPPC Directive 96/61/EC. Nevertheless, this is NOT without difficulties. Nanotechnology projects are not listed in the mandatory impact assessment list under the EU impact assessment directive (see Annex II), so states may exempt them from impact assessment obligation, by relying solely on the directive . Lack of effects data will also prevent stakeholders from conducting assessments.

The case with the IPPC directive is similar. The IPPC deals with limiting the amount of "emission" of pollutants, which is irrelevant with regards to nanoparticles. It has been mentioned in several researches that it is the size, surface structure, solubility and shape of the nanomaterials that contributes to its toxicity, and not the amount/weight.

Last but not least, although nanotech is not specifically regulated, there are general principles of EU Law that will safeguard public health and the environment. The EU is known to be a strict adherent of precautionary principle, so recklessness with regards to the production or research of nanomaterials will arise liability. There could be special cases where nanotech is categorized under strict liability, for example in its connection with military uses. There is yet an established due dilligence rule with regard to nanotechnology, but to avoid law suit, it could be safer to refer to the emerging "best practices" and to the formal position of the EU as reflected on its action plans, communications or existing directives and regulations.

(Hat Tip to Nanologue and Prof Geert van Calster!)