Posts Tagged Chemicals
Do the newly negotiated EU rules on endocrine disruptors illustrate regulatory chill /the ‘freezing effect’ of international trade law?
The new European Commission proposals on endoctrine disruptors are, of course’ ‘science based’. It has been reported (EurActiv, 12 December 2016 and last consulted by me on 13 December) that publication of the proposals was followed by a closed door meeting (minutes of which were released only after a freedom of information request) between the EC and a select number of countries (US, Canada, Argentina, Brazil and Uruguay on 13 July this year). Discussion centered around the potential WTO incompatibility of parts of the EC proposal, particularly those surrounding the tolerance levels for endocrine disruptors present in imported substances (food and feed in particularly). The EC reportedly are prepared to replace “negligible exposure” with “negligible risk from exposure”. The EC defend the latter, arguing it might even ban more, rather than less imported substances: for even if there is only negligible exposure, that exposure may still be a risk. Opponents suggest that the insertion of a risk approach has sacrified precaution on the altar of science.
A few comments.
Firstly, the report (and potentially even the EC itself) repeats the misleading assertion that the debate concerns either science or precaution. Precaution is NOT unscientific. The very trigger of the precautionary approach is science.
Next, the case is reported at a time a lot of people are getting jittery about the regulatory co-operation mechanisms in free trade agreements such as CETA and TTIP. The meeting and the subsequent EC reaction to our trading partners’ comments, would then represent an example of the ‘freezing effect’ in international trade: with our trading partners flying the flag of WTO incompatibility, the EU would then have caved in to threats of litigation in Geneva. Yet in reality WTO input by fellow WTO Members is at least as old as the WTO itself, indeed it predates it. The 1978 Tokyo Standards Code already obliged the then GATT Contracting Parties to notify their draft standards to the GATT Secretariat. The very point of notification and transparency is that the issues raised are being discussed and may indeed lead to the draft standard being adopted. Changes made to REACH, to name but one example, reflected concerns of fellow WTO Members and REACH can hardly be said to pander to industry’s demands.
However there needs to be one core appreciation in this process: just as notification serves transparency (anyone can consult the TBT notification gateway to review draft measures that have been notified), so too should the process of review after reception of the comments, be conducted in a transparent manner. This clearly has not happened here. By conducting these meetings in private, and by refusing to release the minutes until prompted to do so, EC services have given the impression that there is more than meets the eye. In times where even CETA has not yet been ratified, that is most definitely the wrong approach.
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.
Under the European Union’s regime on chemicals (REACH), companies manufacturing or importing chemical substances have to notify considerable amounts of data to the European Chemicals Agency (ECHA). Under the general ‘no data, no market’ rule, those chemicals for which no appropriate risk assessment and risk management has been carried out, cannot be put on the market. What may seem a futile part of compliance – paying the correct registration fee – has now come back to haunt several companies.
ECHA’s machinery needs to be financed. Companies registering substances under REACH to that end pay a registration fee. Micro or small and medium sized enterprises (SMEs) receive a discount. Those incorrectly classifying themselves as small, have now had their comeuppance: ECHA has rejected their registrations, effectively meaning that the companies involved can no longer manufacture or import the substance above one ton per annum.
Lessons are clear. Firstly, one should always be careful with statements of size. Secondly, ECHA bites. It is one of only a few of the European Union’s Agencies which is truly ‘regulatory’ (also on issues of chemicals policy much more relevant than size).