Posts Tagged Risk management

Now you see me, now you don’t. The CJEU on the precautionary principle in Fidenato.

Hang on a minute. Were not the EU and its Member States supposed to be precaution obsessed? Don’t the EU and its Member States alike adopt bans on all things GMO for no other reason than that they simply do not want them? How then can the CJEU hold in C-111/16 Fidenato that Member States do not have the option of adopting, in accordance with Article 54 of Regulation 178/2002, the EU’s general food safety law, interim emergency measures solely on the basis of the precautionary principle?

The reason lies in pre-emption, aka exhaustion, and in the balance between EU and national risk management which EU law strikes in the specific field of GM cultivation. Of note is that in the meantime most biotech companies have given up on cultivation of GM varieties in the EU.

As extremely well summarised by Bobek AG in his Opinion in the case, the formulation of the relevant EU legislation is such as to provide that post EU authorisation (here: of genetically modified maize MON 810) Member States may only take emergency measures where the continued cultivation of the approved products is ‘likely to constitute a serious risk’. While the precautionary principle may play its role fully at the level of the EU’s risk management preceding authorisation, and indeed post such authorisation, too, Member States are given less leeway in their national emergency measures. In prescribing these rules, the EU safeguards the harmonised approach to the GM varieties at issue.

(Mr Fidenato nb is something of a cause celebre among the GM community). Please note, again, that the case concerns the growing (‘cultivation’) of GM crops. Not the import, export or use of products containing GM.

Finally it is important to point out that the Court does not equate precaution with the absence of science. It is the degree of scientific certainty here which is relevant, not the absence ‘v’ presence thereof.


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Amino acids, foodstuffs and precaution. The CJEU disciplines Member States in Queisser Pharma.

There is as yet no EU harmonisation on amino acids, in so far as they have a nutritional or physiological effect and are added to foods or used in the manufacture of foods. A range of EU foodlaws therefore do not apply to national action vis-a-vis amino acids, in particular Regulation 1925/2006 – the food supplements Regulation. In the absence of specific EU law rules regarding prohibition or restriction of the use of other substances or ingredients containing those ‘other substances’, relevant national rules may apply ‘without prejudice to the provisions of the Treaty’.

In C-282/15 Queisser Pharma v Germany, moreover there were no transboundary elements: Articles 34-36 TFEU therefore do not in principle apply.

No doubt food law experts may tell us whether these findings are in any way unusual, however my impression is that the Court of Justice in this judgment stretches the impact of the ‘general principles of EU food law’ as included in Regulation  178/2002. Indeed the Court refers in particular to Article 1(2)’s statement that the Regulation lays down the general principles governing food and feed in general, and food and feed safety in particular, at EU and national level (my emphasis). Article 7 of the Regulation is of particular relevance here. That Article gives a definition of the precautionary principle, and consequential constraints on how far Member States may go in banning foodstuffs, as noted in the absence of EU standards and even if there is no cross-border impact.

Article 7 Precautionary principle

1. In specific circumstances where, following an assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure the high level of health protection chosen in the Community may be adopted, pending further scientific information for a more comprehensive risk assessment.

2. Measures adopted on the basis of paragraph 1 shall be proportionate and no more restrictive of trade than is required to achieve the high level of health protection chosen in the Community, regard being had to technical and economic feasibility and other factors regarded as legitimate in the matter under consideration. The measures shall be reviewed within a reasonable period of time, depending on the nature of the risk to life or health identified and the type of scientific information needed to clarify the scientific uncertainty and to conduct a more comprehensive risk assessment.

Germany on this point is probably found wanting (‘probably’, because final judgment on the extent of German risk assessment is left to the national court) – reference is best made to the judgment for the Court’s reasoning. It is clear to me that the way in which the Regulation defines precaution, curtails the Member States considerably. Further ammunition against the often heard, and wrong, accusation that the EU is trigger happy to ban substances and processes in the face of uncertainty.



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Quattuor, not trias politica. Delegation of legislative power to agencies. Gorsuch addresses the Montesquieuan elephant in the room.

Thank you Alison Frankel at Reuters for bringing to my attention Gutierrez-Brizuela v. Lynch. An immigration case which triggered a delightfully written judgment by Gorsuch CJ on the delegation of power to agencies. In particular the founding fathers’ intention, against the background of separation of powers,  with agencies room for statutory interpretation.

Both Ms Frankel’s article and judge Gorsuch’s pieces do much more justice to the debate than I can do in a blog post so I will leave readers first of all to read both. Judge Gorsuch, referring to precedent (Chevron in particular), notes

‘There’s an elephant in the room with us today. We have studiously attempted to work our way around it and even left it unremarked. But the fact is Chevron and Brand X permit executive bureaucracies to swallow huge amounts of core judicial and legislative power and concentrate federal power in a way that seems more than a little difficult to square with the Constitution of the framers’ design. Maybe the time has come to face the behemoth.’

Ms Frankel notes that Chevron directed courts defer to executive-branch agencies in the interpretation of ambiguous statutes. Justice Gorsuch reviews what exactly was intended by Chevron and points to the difficulty in excessive deferring to agencies’ interpretation of statutes.

I would summarise his views as ‘Congress meant trias, not quattuor politica.’

My knowledge of US civil procedure does not stretch to understanding what impact Gorsuch CJ’s views have on current US administrative /public law. Anyone out there who can tell me please do. At any rate, the judgment is great material for comparative constitutional law classes, the CJEU’s ECB (C-270/12) case being an obvious port of call.


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Not on my soil! The Council of the EU compromise on national vetoes to GMO cultivation.

The Council has published its first-reading position on a draft directive granting member states more flexibility to decide whether or not they wish to cultivate genetically modified organisms(GMOs) on their territory – I had flagged it here before I had an opportunity chance to look at the text. My initial reaction is confirmed however.

Under the text, the possibility would be provided for a Member State to request the Commission to present to the notifier/applicant its demand to adjust the geographical scope of its notification/application to the effect that all or part of the territory of that Member State be excluded from cultivation. The Commission shall facilitate the procedure by presenting the request of the Member State to the notifier/applicant without delay and the notifier/applicant should respond to that request within an established time-limit. In the event of refusal, the Member State may block cultivation on its territory for reasons other than the scientific assessment which will have been carried out by the relevant authorities. (And note that the EC may after refusal also proceed to adjusting geographically the request for authorisation for scientific reasons).

The list of ‘compelling reasons’ which may lead a Member State to refuse cultivation, is non-exhaustively listed as

(a) environmental policy objectives distinct from the elements assessed according to the Directive and to Regulation 1829/2003;  (since those environmental objectives will have been considered in the scientific assessment);

(b) town and country planning;

(c) land use;

(d) socio-economic impacts;

(e) cross-contamination with other products;

(f) agricultural policy objectives; and

(g) public policy.

Those grounds may be invoked individually or in combination, with the exception of the public policy exception (which awkwardly needs to be coupled with one of the other grounds). An authorisation procedure will apply (with no need to apply the transparency Directive, 98/34, concurrently).

An important point to note is that the Directive only applies to growing (‘cultivation’) of GMOs in situ: not to the import, marketing etc. of GMO containing products, food, feed etc. I would not be surprised that in practice this will mean a continuation of industry practice to leave the EU altogether for growing GMOs, focusing its efforts instead on securing authorisation to market. (This regime does not feature the much wider leeway for non-science driven objections).

Today is the Saint’s Day of Saint Ignatius Loyola, founder of the Jesuits. A suitable day to ponder a proposal heavy with risk analysis, regulatory theory,  and trade law implications.


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Thank you for not displaying. Objections to tobacco display ban go up in smoke.

I have previously referred to the display ban case which Philip Morris took to the EFTA Court. I have only just recently stumbled across the eventual holding of the court which had referred the case to Luxembourg. (The Norwegian court held a year after EFTA’s judgment). Not GAVClaw style to report close to 2 years after date of issue: blame the inadequate (read lack of) system by which EFTA and indeed EU Member States report back on their eventual findings in preliminary review.

The District Court had been instructed by the EFTA Court to review whether the display ban actually affects the sale of domestic products and sale of goods from other EEA States equally. If there is de facto equal treatment, the law surfs on Keck & Mithouard’s exception for ‘selling arrangements’: no infringement of the core prohibition on quantitative restrictions to trade in the first place. (See Alberto Alemanno’s analysis of the EFTA ruling for background).

The national court suggested that the EFTA Court had not been entirely clear on how that test had to be constructed: not at any rate, it held, as a market hindrance test: i.e. that new products’ chances of entering the Norwegian tobacco market should be decisive for the question of whether a restriction exists.  It referred inter alia (at p.35 of the copy referred to above) to the fact that the Norwegian Government in its submission to the EFTA Court had suggested that even though such hindrance for new products at the time did not actually exist, it could be expected indeed hoped that this would be the case. The District Court held that in the light of this acknowledgement by the Government, had the EFTA Court found this problematic, it would and should have said so explicitly. (This in some ways might be seen as a risk for the EFTA Court’s tradition, in line with the ECJ’s approach, to practice judicial economy).

The District Court in the end decided to continue the case on the basis of whether national products have a more favourable position due to local habits and customs linked to tobacco use (at p.35): the burden of proof whether the ban actually and not just potentially affects the marketing of imported tobacco products differently than domestic tobacco products lies with PMI, the Court held. That, it said, was not established with clarity: the de facto discriminatory effect of the display ban was found to be too uncertain to be considered a trade barrier.

The Court then somewhat inconsistently (do Norwegian courts practice wide obiter?) did review suitability and proportionality (not needed if Keck & Mithouard applied). Here, without naming the precautionary principle, the Court applies an important consequence often associated with it: the reversal of burden of proof. The Court essentially wanted PMI to show clear evidence for the display ban not being suitable for restricting the consumption of tobacco in Norway, at any rate in the long term (p.48). The Court essentially relies on previous case-law on tobacco advertising and equates suitability of the display ban with relevant studies and case-law on advertising restrictions. This was bound to (although the court took some length to establish it) lead to a finding of suitability.

Finally, as for proportionality proper, the court (with cross-reference i.a. on the effect of these bans elsewhere) did not find less trade restrictive alternatives (within the context of access to information or branding at point of sale).

This judgment just has to be staple fodder for risk classes and the interaction between risk analysis and trade law.


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Now Denmark joins the nano notification fray.

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.


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Beggars can’t be choosers: has the EU’s GMO compromise outsourced moral reservation?

The compromise (official minutes of the Meeting concerned reveal very little detail; more is available here) between the EU Member States on the market authorisation for GMOs has been condemned by opponents and proponents of the technology alike. Market authorisation for GMOs has a long and troublesome history in the EU, with most recently the spat over Pioneer 1507.

I would love to get my hands on any kind of legal formulation for the apparent deal which as been struck. As is common knowledge, some Member States object categorically to GMOs on a mix of scientific (precautionary), moral, sustainability grounds. The EU have for some time been trying to find a way to accommodate moral objections in particular. (Where there are serious indications of scientific uncertainty vis-a-vis a particular application, these are picked up by EFSA and authorisation will be refused for the EU as a whole: this is not problematic per se – lest of course per the US arguments at the WTO in EC Biotech, one does not accept that there is scientific uncertainty). The suggested way out is now, apparently, for the Member States concerned to request the applicant companies, via the European Commission, to exclude their territory from the application.

This raises all sorts of questions. (Including exam questions). It near-effectively outsources regulatory autonomy to the applicant companies. The suggested regime reminds me of the Voluntary Export Restraints which were popular(ish) in the 1980s – and highly controversial under GATT. Under the WTO, they are all but blacklisted. Especially after SEAL pups I believe it would be much better for the EU regime itself to allow opt-out, even of individual Member States, on moral or ethical grounds (again, the scientific debate is different) and to take any WTO fight into open field.

Should anyone out there have the actual text which is being tabled (in the UK English sense of the word) – and the liberty to share it, I would love to hear from you. (Postscript 31 July 2014: see later post with link to text).



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