Posts Tagged Risk
The CJEU held yesterday in Case C-296/16P Dextro Energy (text of judgment available in French and German only at the time of posting), an appeal against the General Court’s ruling in T-100/15. The General Court had declined to annul the European Commission Regulation which refused to authorise certain health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health. Dextro Energy had wanted to include health claims such as ‘glucose supports normal physical activity’ and ‘glucose contributes to normal muscle function’. The EC had refused: citing (in Regulation 1215/8)
‘Pursuant to Articles 6(1) and 13(1) of Regulation … No 1924/2006 health claims need to be based on generally accepted scientific evidence. Authorisation may also legitimately be withheld if health claims do not comply with other general and specific requirements of Regulation … No 1924/2006, even in the case of a favourable scientific assessment by [EFSA]. Health claims inconsistent with generally accepted nutrition and health principles should not be made. [EFSA] concluded that a cause and effect relationship has been established between the consumption of glucose and contribution to energy-yielding metabolism. However, the use of such a health claim would convey a conflicting and confusing message to consumers, because it would encourage consumption of sugars for which, on the basis of generally accepted scientific advance, national and international authorities inform the consumer that their intake should be reduced. Therefore, such a health claim does not comply with point (a) of the second paragraph of Article 3 of Regulation … No 1924/2006 which foresees that the use of claims should not be ambiguous or misleading. Furthermore, even if the concerned health claim was to be authorised only under specific conditions of use and/or accompanied by additional statements or warnings, it would not be sufficient to alleviate the confusion of the consumer, and consequently the claim should not be authorised.’
The General Court performed its standard review in the face of a wide discretionary room for manoeuvre for the EC, and decided the EC had not exceeded its authority in holding as it did – even in the face of more lenient EFSA recommendations. The Court of Justice has now entirely sided with the General Court. The Judgment is a good reminder of aforementioned standard test (no de novo or merits review; annulment in the event of manifest transgression of power or error in judgment only), and readers best refer to reading the judgment itself.
One consideration however, I should like to highlight: Dextro Energy had suggested the health claims needed to be assessed in light of the target group (determined in the product’s advertising), which, it was suggested, were physically active people for whom consumption of the glucose tablets in question is not harmless. The Court rejected this approach: the population as a whole, for whom the product is available, are the group which the EC justifiably seeks to protect. The manufacturer’s professed target group is not the relevant group to consider (do bear in mind that this is a product which is widely available and not restricted in any way at points of sale):
At 76-77: si les allégations de santé en cause étaient autorisées, elles s’adresseraient à la population en général, pouvant ainsi encourager la consommation de sucres par les personnes autres que les hommes et les femmes bien entraînés. Dans ces conditions, le Tribunal n’a pas commis d’erreur de droit lorsqu’il a rejeté, au point 57 de l’arrêt attaqué, l’argument de Dextro Energy, selon lequel c’était le groupe cible qui importait aux fins de l’appréciation des allégations de santé en cause.
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.
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.
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.
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.
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.