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.