Posts Tagged Precaution
In T‑574/18 Agrochem-Maks the General Court at the end of May upheld the Commission Regulation not extending market authorisation for the active substance oxasulfuron, a pesticide. The EC Regulation noted that EFSA, the European Food Safety Authority, had identified a large number of data gaps resulting in the inability to finalise the risk assessment in several areas and that ‘in particular, the available information on oxasulfuron and its metabolites did not allow finalising the assessment of the overall consumer exposure, the groundwater exposure, the risk to aquatic organisms, earthworms, soil macro and microorganisms and non-target terrestrial plants’. Since ‘it has not been established with respect to one or more representative uses of at least one plant protection product that the approval criteria provided for in Article 4 of Regulation … No 1107/2009 [on plant protection products; see here, GAVC] [were] satisfied’, authorisation was not renewed.
The case at issue is brought by a small Croatian, family-owned company. That is a change from the classic pattern in this kind of cases, with large bio-agricultural industry routinely taking cases to the CJEU in laser-shoot fashion, hoping they might hit the target once or twice.
The General Court extensively outlines the procedure foreseen in the relevant EU laws, thereby identifying the core issue in near all of these cases held under the precautionary principle: the EU courts do not carry out a merits review; rather, they assess whether holes have emerged in the preparation of a decision, which could mean that the Institutions could not reasonably have come to the decision they came to.
That is no different here: at 62: ‘the EU Courts must verify that the relevant procedural rules have been complied with, that the facts admitted by the Commission have been accurately stated and that there has been no manifest error of appraisal or misuse of powers’. At 65, per CJEU T-13/99 Pfizer: ‘a scientific risk assessment carried out as thoroughly as possible on the basis of scientific advice founded on the principles of excellence, transparency and independence is an important procedural guarantee whose purpose is to ensure the scientific objectivity of the measures adopted and preclude any arbitrary measures.’
Specifically for current Regulation: at 66: ‘the burden of proving that the conditions for approval or renewal under Article 4 of Regulation No 1107/2009 are met lies, in principle, with the notifier.’ At 67 per CJEU T-584/13 BASF Agro: ‘it is the person seeking approval who must prove that the conditions of such approval are met in order to obtain it, and not the Commission which must prove that the conditions of approval are not met in order to be able to refuse it’.
The General Court then at length considers the procedure followed, including the reasons for the identified gaps, and then assesses the application of the precautionary principle to same: at 109 ff with reference to the 2000 Communication on the Precautionary Principle, COM(2000)1. Crucially, at 121, as noted ‘(u)nder Regulation 1107/2009 when the applicant words its renewal application, it bears the burden of proving the efficacy and safety of the substance in question.’ ‘Since it did not discharge that burden, the approval of the active substance could not be renewed.’
The case highlights once again the crucial nature of administrative compliance with the rulebooks under EU regulatory law. Many of us will have sat through presentations by EFSA or EC officials outlining the rules in excruciating and yes, not very sexy detail. Yet to follow procedure to a tee is crucial to ensure defence against corporations taking issue with the findings at the CJEU.
The case also emphasises the importance of burden of proof, as specified in the secondary law at issue and, preferably, the ‘no data, no market’ rule in EU regulatory law.
There might of course still be an appeal with the Court.
EU environmental law (with Leonie Reins), Edward Elgar, 2018, p.28 ff.
Kenyon: Court of Appeal emphasises again the discipline of the precautionary principle (here: in EIA proceedings).
Update 24 March 2020 thank you Gordon Nardell QC for pointing me to R (Merricks) v Secretary of State for Trade and Industry  EWHC 2698 (Admin), most probably the first case to consider the standard of review when an administrative authority applies the precautionary principle.
A quick note on Kenyon v Secretary of State for Housing Communities & Local Government et al  EWCA Civ 302 in which Coulson J checks planning consent ia against the requirements of the EU Environmental Impact Assessment- EIA Directive 2011/92. Of particular interest is his application of the Wednesbury judicial review test.
At 12: ‘A decision as to whether a proposed development is or is not likely to have significant effects on the environment can only be struck down on Wednesbury grounds’. ‘Wednesbury unreasonableness‘ is akin to CJEU standard of judicial review. Diplock J formulate it later as an administrative decision being annulled only if it was ‘So outrageous in its defiance of logic or accepted moral standards that no sensible person who had applied his mind to the question to be decided could have arrived at it.’ The grounds in Wednesbury are very akin to the CJEU grounds: annulment will follow only if (well summarised by Wiki):
- in making the decision, the defendant took into account factors that ought not to have been taken into account, or
- the defendant failed to take into account factors that ought to have been taken into account, or
- the decision was so unreasonable that no reasonable authority would ever consider imposing it.
Applied at issue at 63 ff to the precautionary principle, applicant’s argument that ‘inevitable air pollution caused by the development’ must be taken into account, fails. at 67: ‘In circumstances where there was no doubt in the mind of the relevant decision-maker, there is no room for the precautionary principle to operate.’ (Clearly and in applying all Wednesbury principles, that absence of doubt must have followed from the right information having been taken into account).
EU environmental law (with Leonie Reins), Edward Elgar, 2018, p.28 ff.
Confédération Paysanne, precaution and GMOs. French High Court issues its final ruling taking CJEU findings to their logical conclusion.
A short post to flag the French Conseil d’Etat’s final ruling in which on 7 February it held that organisms obtained via in-vitro mutagenesis techniques should be subject to GMO regulation and that consequently as EurActiv summarise the French authorities must update regulation to include such crops within six months, which includes identifying the agricultural plant varieties which have been obtained by these techniques and subjecting them to the assessments applicable to GMOs.
The ruling follows the CJEU’s mutagenesis finding in C-528/16, reviewed at the time on Steve Peers’ blog here and subsequently by KJ Garnett in RECIEL here. The ruling put agro-bio industry narrators in a spin but in essence is an utterly logical consequence of EU law.
In C‑212/18 Prato Nevoso Termo Energy the CJEU held on the not always straightforward concurrent application of the Waste Framework Directive (WFD) 98/2008 and the various Directives encouraging the uptake of renewable energy. It referred i.a. to the circular economy and to precaution.
On the face of it the economic and environmental benefits of the case may seem straightforward. Prato Nevoso operates a power plant for the production of thermal energy and electricity. It applied for authorisation to replace methane as the power source for its plant with a bioliquid, in this case a vegetable oil produced by ALSO Srl, derived from the collection and chemical treatment of used cooking oils, residues from the refining of vegetable oils and residues from the washing of the tanks in which those oils were stored. ALSO has a permit to market that oil as an ‘end-of-waste’ product within the meaning of relevant Italian law , for use in connection with the production of biodiesel, on condition that it has the physico-chemical characteristics indicated in that permit and that the commercial documents indicate ‘produced from recovered waste for use in biodiesel production’.
Prato Nevoso was refused the requested authorisation on the ground that the vegetable oil was not included in a relevant Italian list, which sets out the categories of biomass fuels that can be used in an installation producing atmospheric emissions without having to comply with the rules on the energy recovery of waste. The only vegetable oils in those categories are those from dedicated crops or produced by means of exclusively mechanical processes.
The argument subsequently brought was that the refusal violates Article 6 WFD’s rules on end-of-waste, and Article 13 of the RES Directive 2009/28. That Article essentially obliges the Member States to design administrative procedures in such a way as to support the roll-out of renewable energy.
The CJEU first of all refers to its finding in Tallina Vesi that Article 6(4) of Directive 2008/98 does not, in principle, allow a waste holder to demand the recognition of end-of-waste (EOW) status by the competent authority of the Member State or by a court of that Member State. MSs have a lot of flexibility in administering EOW in the absence of European standards. That the use of a substance derived from waste as a fuel in a plant producing atmospheric emissions is subject to the national legislation on energy recovery from waste, is therefore entirely possible (at 39). A13 of the RES Directive has no impact on that reality: that Article does not concern the regulatory procedures for the adoption of end-of-waste status criteria.
Nevertheless, the MS’ implementation of the RES Directives must not endanger the attainment of the WFD, including encouragement of the circular economy etc. and likewise, the WFD’s waste hierarchy has an impact on the RES’ objectives. A manifest error of assessment in relation to the non-compliance with the conditions set out in Article 6(1) of Directive 2008/98 could be found to be a MS violation of the Directive.
At 43: ‘It is necessary, in this case, to examine whether the Member State could, without making such an error, consider that it has not been demonstrated that the use of the vegetable oil at issue in the main proceedings, in such circumstances, allows the conclusion that the conditions laid down in that provision are met and, in particular, that that use is devoid of any possible adverse impact on the environment and human health.’ At 44: ‘It is for the national court, which alone has jurisdiction to establish and assess the facts, to determine whether that is the case in the main proceedings and, in particular, to verify that the non-inclusion of those vegetable oils in the list of authorised fuels results from a justified application of the precautionary principle.’
At 45 ff the CJEU does give a number of indications to the national judge, suggesting that no such infringement of the precautionary principle has occurred (including the reality that specific treatment and specific uses envisaged of the waste streams, has an impact on their environmental and public health safety). At 57: It must be considered that the existence of a certain degree of scientific uncertainty regarding the environmental risks associated with a substance — such as the oils at issue in the main proceedings — ceasing to have waste status, may lead a Member State, taking into account the precautionary principle, to decide not to include that substance on the list of authorised fuels’.
An important judgment.
Handbook of EU Waste law, 2nd ed. 2015, OUP, 1.166 ff and 1.189 ff.
Update 18 May 2020 confirmed today by the Court of Appeal in  EWCA Civ 649.
Hot on the heels of yesterday’s post on e-collars, a short note on yet another trade and animal welfare /biodiversity case. In  EWHC 2951 (Admin) Friends of Antique Cultural Treasures v Secretary of State for the environment, food and rural affairs, Justice Jay (‘Jay J’ even though correct might sound a bit too intimate) upheld the UK’s planned ban on ivory trade, stricter than anything in place elsewhere. As a general rule, the Act interdicts the sale of antique worked ivory, that is to say pre-1947 artefacts, unless one of limited exemptions is applicable.
The discussion engages CITES, pre-emption /exhaustion by harmonised EU law, the environmental guarantee of Article 193 TFEU (albeit not, oddly, the issue of notification to the EC), Article 34 TFEU, and A1P1 ECHR.
On uncertainty, Justice Jay refers to the precautionary principle: at 155: ‘we are in the realm of scientific and evidentiary uncertainty, and the need for a high level of protection. §3.1 of the Commission’s 2017 Guidance makes that explicit. Although the evidence bearing on the issues of indirect causation and demand in Far Eastern markets may be uncertain, statistically questionable, impressionistic and often anecdotal, I consider that these factors do not preclude the taking of bold and robust action in the light of the precautionary principle.’
Rosalind English has analysis here and refers even to Edmund de Waal’s novel The Hare with the Amber Eyes which has been on my reading list after my wife recommended it – this is a good reminder.
EU environmental law (with Leonie Reins), Edward Elgar, 2018, p.28 ff., and Chapter 17 (p.308 ff).
Rather than blogging my own piece on this week’s CEPS study (in which no mention is made of the covert study supporting same), I am happy to reblog the analysis of one of the co-authors of my earlier paper on same. Excellent analysis with which I agree entirely.
K J Garnett
On the day before Commission President Ursula von der Leyen’s new team was voted in by the European Parliament, an independent, Brussels-based, think-thank CEPS published their third report on the Innovation Principle : ‘Study supporting the interim evaluation of the innovation principle’. With von der Leyen promising to tackle climate change and promote a European Green Deal now would be a good time to examine whether the innovation principle fits in with this vision for greater sustainability or whether its true intention is to curb Europe’s strict environmental laws?
As lawyers we are familiar with general principles and those practicing European law are familiar with the fact that the EU applies a number of general principles : proportionality, subsidiarity, substantive & fundamental human rights, precaution,… Authority for the EU’s legal principles stems from primary law, typically the Treaties themselves or, more rarely, when the CJEU…
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Starting with the infamous and fundamentally flawed Laws of Fear by Cass Sunstein, Europe’s precautionary principle has been under constant attack by industry both within and outside of the EU. My postings on the principle here and the section on it in my Handbook of EU environmental law with Leonie Reins attempt to show that despite industry propaganda against it, the principle has never been a blind ‘when in doubt, don’t do it’ approach to risk management.
In C-616/17 Blaise and others, the Court once again shows its measured approach. Defendants in national criminal proceedings, argued that they should be let off in a criminal damage prosecution. They are environmental activists and are charged with causing criminal damage to containers of herbicidal products (specifically ‘Roundup’) containing the chemical glyphosate. In their defence, they argue that the products present an unacceptable potential risk to human health and the environment and that the EU approval process is defective and therefore unlawful.
The Court found that the approval process on the basis of EU law is entirely in line with EU law, including the precautionary principle. Steptoe have excellent overview here and I am happy to refer entirely.
EU environmental law (with Leonie Reins), Edward Elgar, 2018, p.28 ff.
A short update on the innovation principle‘s continued (corporate-sponsored, let’s be frank) journey.
Thank you first of all prof Maria Lee for signalling the UK’s planned introduction of an ‘innovation test’, to be piloted as part of industrial strategy. Its goal is expressed as ‘We will create an outcome-focused, flexible regulatory system that enables innovation to thrive while protecting citizens and the environment.’ Not much more detail is given. Formulated as such, it does nothing that the current EU regulatory model does not already address – its true goal undoubtedly is a post-Brexit libertarian regulatory environment.
Further, Nina Holland observed with eagle eyes the link between Nafta 2.0 (USMCA) and innovation, in particular Article 12-A-4 ‘parties’ “recognize the importance of developing and implementing measures in a manner that achieves their respective level of protection without creating unnecessary economic barriers or impediments to technological innovation’ (like the UK initiative: meaningless for already addressed by current international trade agreements; the real intention actually is deregulation). American industry has been arguing that the US should ‘build on’ the new NAFTA when negotiating with the EU (should TTIP ever be resuscitated).
Ghostbusters and the Marshmallow Man. The European Commission covert consultation and study on the innovation principle.
I have reported before on the innovation principle, the industry efforts behind it and the European Commission response to same. I have linked our initial paper as well as media and other reports in an earlier posting. The most comprehensive overview of the genesis of the principle is included here.
One of the comments I made in that earlier post is that Commissioner Moedas has emphasised verbatim that the innovation principle is not binding EU law: ‘“I think we have some misunderstanding here … The Horizon Europe proposal does not in any way establish the innovation principle or incorporate it into EU law. It is referred to in the recitals but it is not something that is [in] the proposal,” he said.
At the end of the original Ghostbusters movie, a giant Marshmallow Man appears as a result of the main ghost’s conjuring up himself as the physical manifestation of the first thought popping up into the mind of the lead characters’ mind (further info here). The road to turning the imagination of the innovation principle into reality is currently equally continuing with no less than a Commission-ordered Consultation Report, from the Centre for European Policy Studies, on the evaluation of the innovation principle: see the Directorate-General’s invitation letter and the questionnaire.
Both documents reached me via a little Berlaymont bird. I have anonymised individuals mentioned in the documents and I have also changed the order of questions in the questionnaire just in case individual copies were drafted to facilitate the coveted ‘confidentiality’ – contents of the questionnaire have stayed the same. The questionnaire is meant for ‘selected stakeholders’ who are instructed not to ‘share, quote or cite it’.
The principle even if it does exist certainly does not do so in EU law – as confirmed by the Commissioner. Yet it is his DG which has instructed CEPS to carry out the study, confidentially: not exactly a driving principle of the Better Regulation Agenda to which the documents purport to answer.
The invite states that ‘the overall aim of this evaluation is to describe the status quo and prepare recommendations for future action in accordance with the better regulation guidelines. These recommendations will serve to apply the Innovation Principle in a way which helps the achievement of EU policy objectives and is consistent with identified stakeholder needs.’
The text pays lip service to the general interest which ‘innovation’ is meant to serve, yet also repeatedly emphasises that existing regulatory hurdles to ‘innovation’ ought to be classified and potentially removed; that the EC may take the necessary steps to initiate this; and nowhere does it question the very existence of the principle.
It is noteworthy in this respect that Horizon Europe, Europe’s next flagship research and development program, refers drastically less to responsibly research and innovation -RRI than did its predecessor. Parliament did not halt references to the innovation principle in its recitals.
I would like to emphasise again that with my co-authors of the paper, I am not an unshakable opponent of the introduction of an innovation principle. Provided the discussion on it is done in the appropriate institutions and at the very least in the public domain. A confidential survey confirms the reactionary character which this principle so far represents on the EU scene.
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.