Posts Tagged Risk assessment

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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Biocides rebuke teaches EC to honour dates, and not to use Impact assessment as an excuse.

The CJEU (General Court) sided with Sweden in T-521/14, concerning the failure, by the Commission, to adopt measures concerning the specification of scientific criteria for the determination of endocrine-disrupting properties.

To improve the free movement of biocidal products in the EU, while ensuring a high level of protection of human and animal health and the environment, the EU adopted Regulation 528/2012 concerning the making available on the market and use of biocidal products. It sets out the active substances which, in principle, cannot be approved. They include active substances which, on the basis of criteria to be established, are regarded as having endocrine-disrupting properties which may be harmful to humans, or which have been designated as having those properties. It also provides that, by 13 December 2013 at the latest, the Commission was to adopt the delegated acts as regards the specification of the scientific criteria for the determination of endocrine-disrupting properties.

The EC cited criticism  following its presentation of draft scientific criteria, as well as the need to make the various possible solutions subject to an impact assessment. The CJEU first of all held that the Commission had a clear, precise and unconditional obligation to adopt delegated acts as regards the specification of the scientific criteria for the determination of the endocrine-disrupting properties and that that was to be done by 13 December 2013.

With respect to the impact assessment, the General Court finds that there is no provision of the regulation which requires such an impact analysis. What is more, even if the Commission ought to have carried out such an impact analysis, that does not in any way exonerate it, in the absence of provisions to that effect, from complying with the deadline set for the adoption of those delegated acts.

I like this judgment (it will no doubt be appealed by the EC). It reinforces the need to respect clearly defined dates and deadlines. And it takes a bit of the shine off impact assessments, the duration, extend, and lobbying of which can often lead to death by impact analysis.



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That sucks: CJEU on science, testing, and laboratories in Dyson.

At first sight, it may seem a bit nerdy to report on Dyson, Case T-544/13. Yet (pun alert) once the dust settled on the judgment, the case in my view reveals quite a lot on how the CJEU sees the role of the EC as a regulator involved in all three steps of risk analysis: risk identification; risk management; and risk communication.

Arguably, misleading information often does more damage than a lack of information. It is on this basis that well-known Dyson, producer ia of bagless hoovers (or vacuum cleaners), challenged a delegated EC Regulation which establishes, in its own wording, ‘labelling and the provision of supplementary product information for electric mains-operated vacuum cleaners, including hybrid vacuum cleaners’. The purpose of the Regulation and of its mother Directive on energy labelling, evidently is to encourage consumers to purchase hoovers using less energy.

The contested regulation requires tests conducted with an empty dust bag. That, Dyson essentially argues, is like testing a Ferrari and a 2 CV on fuel consumption, with both cars in stationary condition (my comparison, not theirs). It will, in Dyson’s plea, lead to: (i) reporting of inaccurate information; (ii) ‘during use’ information not being integrated into the energy performance data; (iii) less incentive for manufacturers to invest with a view to improving the energy efficiency of vacuum cleaners; and (iv) labelling which does not serve to attain the objective of reducing energy consumption and, on the contrary, leads to an increase in energy consumption.

The Court held (at 47) that the Commission cannot be criticised for having failed to require tests conducted with a dust-loaded receptacle if, under its broad discretion, it decided that such tests were not yet reliable, accurate and reproducible. Even though the Court in various parts of the judgment acknowledges the inadequacy of the resulting product comparison, it cannot be held that the Commission made a manifest error of assessment by favouring a test conducted with an empty receptacle over a test conducted with a dust-loaded receptacle (at 53).

The judgment entertains many arguments brought forward however they essentially all revolve around the seemingly unavailable nature of appropriate, peer reviewable testing methods. The Court dismisses them all as (pun alert) hot air and effectively requires Dyson to offer the peer reviewable, repeatable alternative.

With respect, I believe the judgment is fundamentally mistaken. It was obviously not considered to be of a very crucial nature (chamber of three). Yet despite its very focussed nature, it reveals a lot about what the EU expects of its Institutions. In this case, misinformation is essentially considered preferable to no information. Surely (pun alert) that sucks.

The case was before the General Court hence appeal with the CJEU is not impossible.



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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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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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Germany v Commission re toys: ECJ confirms that recourse to precautionary principle is no walk in the park.

The ECJ this morning held in Germany v Commission (for context see my earlier posting). On 1 March 2012, the European Commission only partially (and temporarily) granted Germany approval for upholding stricter limits on limit values for lead, barium, arsenic, antimony, mercury, nitrosamines and nitrosatable substances in toys (for the decision, see here).
The ECJ stood with Germany only in its appeal against the EC’s decision on values for lead: this decision was internally inconsistent (acknowledgement of higher public health protection in the German measures while at the same time unfounded (and vague) limitation in time for those German measures). However for all other substances, the ECJ rejected Germany’s appeal. In doing so it emphasises the burden of proof which the precautionary principle implies (often misrepresented by opponents of the principle). The review of the available scientific evidence shows first of all the challenges associated with the different methods employed by Germany cq the EC. The latter’s measures employ migration limits (migration being the amount of toxic substances not just released from the product but effectively absorbed by the human body), while Germany’s measures rely on bioavailability (the amount of chemical substances released from the product and available for human absorption, even if not all of that is necessarily effectively absorbed).

The ECJ supports the room for Member States to have divergent opinions on risk than those of the EC, however, it needs to show that the national measures better protect human health and do so in a proportionate way. The crucial shortcoming in Germany’s proof turned out to be that its exposure scenarios were, in the view of the ECJ, unrealistic (and not supported by further scientific reporting): they imply simultaneous exposure of a child to all possible toy safety Directive scenarios: dry, brittle, powder-like or pliable toy material; AND liquid or stocky toy material; AND scraped-off toy material.

Hum. That such simultaneous exposure should necessarily be unrealistic is of course open to debate. Many of us have tales to tell of children achieving the impossible with toys clearly not designed for the game a child or group of children might at some point concoct . (Reminiscent of the inherently flawed furniture endurance tests displayed by large furniture chains: I have always thought that letting our family loose on the displayed piece of kitchen, bathroom or dining room furniture would be a more realistic test than an engineered testroom).

As often with risk assessment and risk management: the final conclusion almost always remains open to discussion.



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