Posts Tagged Nanotechnologies
Denmark has adopted its regime for notification preparations and products containing nanomaterials. (Belgium ‘s regime as far as I am aware has still not been finally adopted – it is not the kind of measure which its care-taker government (coalition negotiations are underway) can justifiably adopt). The final text (Danish only) does differ from the text notified under the EU’s transparency regime, following comments by the EC and by other Member States.
The Danish text (which entered into force last Wednesday, 18 June) differs from the proposed Belgian regime: it targets consumer goods, not professional goods; it does not mutually recognise notification done in other Member States…The Belgian regime in turn differs from the French, and Norwegian (not an EU Member State but EFTA) scheme etc. Harmonisation at the European level is becoming ever more urgent: impact assessment at that level is underway and a proposal expected for the autumn. This will then presumably gazump any pre-existing national regimes.
I reported earlier on the delay incurred by the Belgian nano register. Following objections under the EU’s transparency Directive, the Belgian register stood still. The Belgian Government is now tinkering with the proposal, having reportedly adopted a new draft which is being sent to various consultative bodies.
The new draft, a little bird tells me, adds additinal requirements in the light of occupation health and safety requirements; introduces 1 January 2016 as the deadline for registration of nanomaterials already on the market and 1 January 2017 for relevant mixtures; postpones until later the cut-off date for objects and complex preparations containing nanomaterials; and cancels the exemption for cosmetics containing nanomaterials.
Strangely, for a move designed to increase transparency, the new draft itself is kept under wraps for the time being.
EC, UK et al comments on Belgian nano-register delay its roll-out. No disguise of general unease vis-a-vis EC dithering.
The European Commission, the United Kingdom, The Czech Republic, Italy and Ireland have all issued detailed comments on the ‘nano register’ notified by Belgium.
Belgium itself had summarised the draft as follows:
The draft legislation implements a register of substances manufactured at the nanoscale based on declarations of products containing such substances by the parties placing these products on the market.
To this end, the draft legislation mandates that substances manufactured at the nanoscale, and preparations containing them, be declared if more than 100 grams of these substances are placed on the market per year (the declaration covers the characteristics of the substances, the quantity of substances manufactured at the nanoscale placed on the market, the use of the preparation or substance concerned and the identity of professional purchasers and users).
The draft legislation also lays down an obligation to make a simplified declaration for articles incorporating a substance or substances manufactured at the nanoscale, as long as more than 100 grams are placed on the market per year and the article emits more than 0.1% of substances manufactured at the nanoscale when in use (only a reduced list is required of the characteristics of the substances manufactured at the nanoscale).
Provisions are laid down concerning data protection and confidentiality, as well as concerning research and development activities.
The draft additionally covers the mutual recognition of the numbers of any declarations made by non-Member States, thus reducing the impact of the draft legislation on the free movement of the products concerned.
Under the notification procedure of Directive 98/34, Member States have to notify draft ‘technical regulations’ which may impede the Internal Market. This is followed by a standstill period and by an opportunity for other Member States, and the European Commission, to issue comments. Detailed comments extend the standstill period – in the case of Belgium’s nano register, now until early January 2014.
I am not in fact entirely convinced that the nano register is a ‘technical regulation’ under the Directive – Belgium would seem to have opted for the cautious approach, apparently in contrast with its approach vis-a-vis the mirror provisions under WTO law: the WTO has a similar regime under the Agreement on Technical Barriers to Trade (see also Agapi Patsa and Anna Gergely on same) – albeit with less strict consequences if a Member fails to notify. I was not able to locate Belgium’s notification in the TBT’s IMS This database can be a bit moody, whence Belgium may have notified but I cannot find it. Alternatively, Belgium may have decided that the register does not qualify as a technical regulation under WTO law..
I have not been able (nor have I chased – perhaps some readers have) to get my hands on the comments issued by a handful of Member States and by the EC. . They are likely of course to relate to the impact on nano roll-out of a registration duty in a core Member State.
It is not unlikely that the Belgian initiative is meant in part to put pressure on the EC to beef up its own notification requirements. However the EC is dragging its feet on reporting on the public consultation re REACH and nano, and other Member States, notably Germany, which is pondering a separate notification proposal, are getting impatient, too.
Things are brewing in nano land – European parliament calls for tougher action in wake of national initiatives
The European Commission has recently unveiled a second, updated review of the application of the existing regulatory framework, to nanotechnologies (see here for a link to all relevant studies; and here for an overview of my own work on nano regulation; where possible, they are on ssrn). The first, in 2008, identified the ‘incremental’ approach as the option which the EU would take in regulating nanotechnologies. The second, just out, well, basically confirms this: the Commission continues to be of the view that there is no basis in EU law to apply a moratorium, or some kind of ‘no data, no market’ principle. It is quite happy with the definitional approach in current EU legislation. Finally it uses the accompanying staff working document to give an overview of current initiatives, databases, existing commercial use etc [incidentally, for the uninitiated, staff working documents unlike they rather innocent name, in reality tend to be much more relevant than the actual Communications; they are not subject to translation requirements, escape strict word limits therefore, and tend to be much more detailed].
Quite a bit of attention goes to REACH, the Chemical policy Regulation, and its impact on nanotechnologies, however as the staff working document indicates, there might be other areas of the law, in particular with respect to occupational health and safety, which would have to (indeed are being) looked at more carefully. Frankly, the approach to the regulation of nanotechnologies is a bit like driving a minivan in one of these underground parkings: even if one has checked the maximum height (and the manual of your car confirms one does not exceed it), one still is a little bit tense driving in.
The Greens in the European Parliament have never been convinced of the incremental approach and gave indication of such in their reaction to the new report. Dome EU Member States such as France and The Netherlands would like to see regulation at a quicker pace – starting with transparency as to what is already on the market.
Continuing the minivan reference above: manuals can be wrong, height indicators at parkings ditto: one might end up badly scratching the car or indeed getting it stuck. Late lessons from early warnings comes to mind.
This is not a recent development, however, the US EPA’s filing of a brief in the relevant court case reminded me of the issue. In January last, the National Resources Defense Council – NRDC, announced its seeking to overturn the United States’ Environmental Protection Agency – EPA’s temporary approval of the use of nanosilver in fabrics.NRDC have been joined by others (see e.g. here for amicus curiae brief).
Starting in December 2011, EPA allowed the company HeiQ Materials to sell nanosilver used in fabrics for the next four years as the company completes studies on toxicity to human health and aquatic organisms.
I am not privy to the complete scientific file avalable to EPA and /or HeiQ Materials, however, the case has many familiar rings to it. Undoubtedly HeiQ have conducted their own test. Undoubtedly, too, they pointed EPA to existing studies on the dangers of exposure to nanosilver. However it is clear from reporting on the file that uncertainties remain, in particular with respect to the exposure of infants (who are inclined to chew on their clothes). The challenge is a classic application of the precautionary principle. Should the lack of full certainty lead to a ‘when in doubt opt out’ attitude, or should one adopt an incremental approach, making manufacturers subject to due process (ia in collecting data but also in protecting employees and consumers) and duty of care obligations whilst one awaits further data.
Never a joy for the parties concerned, however one could argue that it is only in litigating that we shall be able to set the boundaries along which regulatory authorities are to conduct themselves in addressing new technologies.