Posts Tagged Burden of proof
French Court annuls market authorisation of Roundup. Contrary to public perception, it neither used nor needed the precautionary principle to do so.
In March 2017, France’s ANSES, the relevant food, environment, and occupational health and safety agency, approved Monsanto’s Roundup Pro 360. That authorisation has now been annulled by the Courts at Lyon – around the same time the story broke of extensive unquestioned copy /pasting by regulators of industry dossiers.
At the beginning of its reasoning the court cites France’s environment charter, to which its Constitution refers. The Charter guarantees everyone in its first Article the right to live in a balanced environment and one with respect for human health. Article 5 entails the precautionary principle, with reference (of course) to scientific assessment and proportionality.
Yet this intro is made for dramatic effect only. The judgment is in fact nothing but a straightforward application of risk assessment requirements on the basis of prevention, not precaution, and a simple observation of infringement of EU law.
At 3 (p.7) the court points out the consequences of the relevant EU authorisation regime. Active ingredients such as glyphosate are authorised (or not; and potentially with conditions) by the EU. Applications in wich these substances are used, by the Member States.
France’s Centre International de Recherche sur le Cancer (CIRC) had classified glyphosate as ‘probably carcinogenic’. Its report on same is referred to by the court as a ‘handbook’, based on peer reviewed studies, the data of which are objectively verifiable as well as replicable. In the other corner, one study referred to by Monsanto (at 7). Relevant EFSA studies only look at the active ingredient and it is these studies upon which ANSES’ decision was based. These studies do not assess the active ingredients’ actual use in preparations such as Roundup Pro 360 which is 41.5% glyphosate. Consequently ANSES quite straightforwardly violates Regulation 1107/2009, particularly its Article 36(6), which prescribes that interaction between the active substance, safeners, synergists and co-formulants shall be taken into account in the evaluation of plant protection products.
The judgment is convincing and straightforward. The road to it was all but easy.
EU environmental law (with Leonie Reins), Edward Elgar, soft cover edition 2018, p.28 ff.
Repeat after me: the precautionary principle does not imply reversal of the burden of proof. Neither does it mean ‘when in doubt, opt-out’.
Allow me a succinct grumble about the precautionary principle. A recent Guardian item on trade talks post-Brexit refers ia to proponents of Brexit wanting to use future trade talks eg with the US, to ditch the precautionary principle. It states the proponents’ strategy ‘also advocates tearing up the EU’s “precautionary principle”, under which traders have to prove something is safe before it is sold, rather than waiting for it to be proved unsafe’.
Reversing the burden of proof (also known as the ‘no data no market rule’) is not a necessary prerequisite of the precautionary principle. If it were, public authorities’ task in regulating health, safety and the environment would look very different than it does today, as would the regulation of new technologies such as nano or synthetic biology (indeed even AI). Only in specific sectors, has the burden of proof been reversed. This includes, in the EU, REACH – the flagship Regulation on chemicals. In others, it was discussed (e.g. in the reform of the EU’s cosmetics Directive into a Regulation), but eventually dismissed.
Neither does the EU’s approach to the precautionary principle imply ‘when in doubt, opt out’, or ‘when in doubt, don’t do it’. One need only refer to the recent decision to extend the licence for glyphosate to show that the EU does not ban what is not proven safe (the least one can say about glyphosate is that its health and environmental safety is not clearly established). I blame Cass Sunstein’s Laws of Fear, superbly reviewed (critically) by Liz Fisher in the 2006 Modern Law Review for misrepresenting the principle – such that even its proponents often misunderstand its true meaning.
Precaution is not an alternative to science. It is a consequence of science.
EU environmental law (with Leonie Reins), Edward Elgar, soft cover edition 2018, p.28 ff.
Refusal of recognition for failure to serve. ECtHR tests the Brussels regime against Strasbourg in AVOTIŅŠ v Latvia
In AVOTIŅŠ v Latvia |Avotins v LAtvia, the Grand Chamber of the ECtHR at Strasbourg held late May that Article 6 ECHR (right to fair trial) was engaged but not infringed by the Latvian’s Supreme Court’s application of Article 34(2( Brussel I (now Article 45(1) b Brussels I Recast).
The Article reads ‘A judgment shall not be recognised: (…) 2. where it was given in default of appearance, if the defendant was not served with the document which instituted the proceedings or with an equivalent document in sufficient time and in such a way as to enable him to arrange for his defence, unless the defendant failed to commence proceedings to challenge the judgment when it was possible for him to do so;…
In the case at issue applicant sought refusal by the Latvian court of recognition of a Cypriot judgment issued against him. After review of the Regulation’s core pedigree of mutual recognition and mutual trust, burden of proof particularly exercised the Court: at 121:
‘The fact that the applicant relied on that Article (34(2), GAVC) without having challenged the judgment as required necessarily raised the question of the availability of that legal remedy in Cyprus in the circumstances of the present case. In such a situation the Senate was not entitled simply to criticise the applicant, as it did in its judgment of 31 January 2007, for not appealing against the judgment concerned, and to remain silent on the issue of the burden of proof with regard to the existence and availability of a remedy in the State of origin; Article 6 § 1 of the Convention, like Article 34(2) in fine of the Brussels I Regulation, required it to verify that this condition was satisfied, in the absence of which it could not refuse to examine the applicant’s complaint. The Court considers that the determination of the burden of proof, which, as the European Commission stressed (see paragraph 92 above), is not governed by European Union law, was therefore decisive in the present case. Hence, that point should have been examined in adversarial proceedings leading to reasoned findings. However, the Supreme Court tacitly presumed either that the burden of proof lay with the defendant or that such a remedy had in fact been available to the applicant. This approach, which reflects a literal and automatic application of Article 34(2) of the Brussels I Regulation, could in theory lead to a finding that the protection afforded was manifestly deficient such that the presumption of equivalent protection of the rights of the defence guaranteed by Article 6 § 1 is rebutted. Nevertheless, in the specific circumstances of the present application the Court does not consider this to be the case, although this shortcoming is regrettable.’
Those ‘specific circumstances’ include in particular the applicant’s professional background: at 124:
‘the applicant, who was an investment consultant, should have been aware of the legal consequences of the acknowledgment of debt deed which he had signed. That deed was governed by Cypriot law, concerned a sum of money borrowed by the applicant from a Cypriot company and contained a clause conferring jurisdiction on the Cypriot courts. Accordingly, the applicant should have ensured that he was familiar with the manner in which possible proceedings would be conducted before the Cypriot courts (…). Having omitted to obtain information on the subject he contributed to a large extent, as a result of his inaction and lack of diligence, to bringing about the situation of which he complained before the Court and which he could have prevented so as to avoid incurring any damage’.
I am not convinced by the Court’s view on the burden of proof and on the national court’s duty to assess the law in the State of origin sua sponte. Judges Lemmens and Briede, jointly concurring but for different reasons as the court, in my view have the better argument where they say
‘If the applicant wanted to argue that no remedy had in fact been available to him in Cyprus, in our opinion it would have been for him to raise this issue explicitly before the Supreme Court. We question whether he could expect the Supreme Court to raise that issue of its own motion. And we definitely consider that he cannot complain under Article 6 § 1 of the Convention about the lack of an explicit response to an argument that was not explicitly made.’
The end result is the same at the ECtHR. For future application of the Brussels I (Recast) Regulation however it makes a big difference.
(Handbook of) European Private International Law, 2nd ed. 2016, Chapter 2, Heading 2.2.16, Heading 184.108.40.206.4 (p.198).
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 – update January 2018: it did not). 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.
Postscript for an example of where Article 4(2)m, lex fori concursus for rules relating to the voidness, voidability or unenforceability of legal acts detrimental to all the creditors, applies without correction, see C-594/14 Kornhaas.
In my posting on Lutz I flagged the increasing relevance of Article 13 of the Insolvency Regulation. This Article neutralises the lex concursus in favour of the lex causae governing the act between a person (often a company) benefiting from an act detrimental to all the creditors, and the insolvent company. Classic example is a payment made by the insolvent company to one particular creditor. Evidently this is detrimental to the other creditors, who are confronted with reduced means against which they can exercise their rights. Article 13 reads
Detrimental acts. Article 4(2)(m) shall not apply where the person who benefited from an act detrimental to all the creditors provides proof that: – the said act is subject to the law of a Member State other than that of the State of the opening of proceedings, and – that law does not allow any means of challenging that act in the relevant case.
In the case at issue, C-310/14, Nike (incorporated in The Netherlands) had a franchise agreement with Sportland Oy, a Finnish company. This agreement is governed by Dutch law (through choice of law). Sportland paid for a number of Nike deliveries. Payments went ahead a few months before and after the opening of the insolvency proceedings. Sportland’s liquidator attempts to have the payments annulled, and to have Nike reimburse.
Under Finnish law, para 10 of the Law on recovery of assets provides that the payment of a debt within three months of the prescribed date may be challenged if it is paid with an unusual means of payment, is paid prematurely, or in an amount which, in view of the amount of the debtor’s estate, may be regarded as significant. Under Netherlands law, according to Article 47 of the Law on insolvency (Faillissementswet), the payment of an outstanding debt may be challenged only if it is proven that when the recipient received the payment he was aware that the application for insolvency proceedings had already been lodged or that the payment was agreed between the creditor and the debtor in order to give priority to that creditor to the detriment of the other creditors.
Nike first of all argued, unsuccessfully in the Finnish courts, that the payment was not ‘unusual’. The Finnish courts essentially held that under relevant Finnish law, the payment was unusual among others because the amount paid was quite high in relation to the overall assets of the company. Nike argues in subsidiary order that Dutch law, the lex causae of the franchise agreement, should be applied. Attention then focussed (and the CJEU held on) the burden of proof under Article 13, as well as the exact meaning of ‘that law does not allow any means of challenging that act in the relevant case.‘
Firstly, the Finnish version of the Regulation seemingly does not include wording identical or similar to ‘in the relevant case‘ (Article 13 in fine). Insisting on a restrictive interpretation of Article 13, which it had also held in Lutz, the CJEU held that all the circumstances of the cases need to be taken into account. The person profiting from the action cannot solely rely ‘in a purely abstract manner, on the unchallengeable character of the act at issue on the basis of a provision of the lex causae‘ (at 21).
Related to this issue the referring court had actually quoted the Virgos Schmit report, which reads in relevant part (at 137) ‘By “any means” it is understood that the act must not be capable of being challenged using either rules on insolvency or general rules of the national law applicable to the act’. This interpretation evidently reduces the comfort zone for the party who benefitted from the act. It widens the search area, so to speak. It was suggested, for instance, that Dutch law in general includes a prohibition of abuse of rights, which is wider than the limited circumstances of the Faillissementswet, referred to above.
The CJEU surprisingly does not quote the report however it does come to a similar conclusion: at 36: ‘the expression ‘does not allow any means of challenging that act …’ applies, in addition to the insolvency rules of the lex causae, to the general provisions and principles of that law, taken as a whole.’
Attention then shifted to the burden of proof: which party is required to plead that the circumstances for application of a provision of the lex causae leading to voidness, voidability or unenforceability of the act, do not exist? The CJEU held on the basis of Article 13’s wording and overall objectives that it is for the defendant in an action relating to the voidness, voidability or unenforceability of an act to provide proof, on the basis of the lex causae, that the act cannot be challenged. Tthe defendant has to prove both the facts from which the conclusion can be drawn that the act is unchallengeable and the absence of any evidence that would militate against that conclusion (at 25).
However, (at 27) ‘although Article 13 of the regulation expressly governs where the burden of proof lies, it does not contain any provisions on more specific procedural aspects. For instance, that article does not set out, inter alia, the ways in which evidence is to be elicited, what evidence is to be admissible before the appropriate national court, or the principles governing that court’s assessment of the probative value of the evidence adduced before it.‘
‘(T)he issue of determining the criteria for ascertaining whether the applicant has in fact proven that the act can be challenged falls within the procedural autonomy of the relevant Member State, regard being had to the principles of effectiveness and equivalence.’ (at 44)
The Court therefore once again bumps into the limits of autonomous interpretation. How ad hoc, concrete (as opposed to ‘in the abstract’: see the CJEU’s words, above) the defendant has to be in providing proof (and foreign expert testimony with it), may differ greatly in the various Member States. Watch this space for more judicial review of Article 13.
Postscript 7 December 2015: Bob Wessels has annotated the case here.
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.