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.

Geert.

EU environmental law (with Leonie Reins), Edward Elgar, soft cover edition 2018, p.28 ff.

Swedish Match: Snus, precaution and the gateway effect.

A short update on the Court of Justice’s ruling in C-151/17 Swedish Match, in which yesterday it upheld the legality of Directive 2014/40’s ban on ‘snus’ and generally on tobacco products for oral consumption. (Sweden is exempt: Article 15(1) of the 1994 Act of Accession).

The Court reaffirms the bite of the precautionary principle; emphasises the ‘gateway effect’ of snus for the young, including intern alia because consumption of snus can be done very discreetly and hence enforcement of an age ban (a suggested alternative) not effective; and the importance of giving precedence to public health over economic profit.

It also, yet again, shows that measures like these do not fall out of thin air because, as proponents of the precautionary principle would suggest, anti-innovation zealots dream up restrictive measures to kill enterprise. Rather, following extensive scientific advice, the ban is a sensible and proportionate measure to take.

Geert.

EU Environmental Law, with Dr Leonie Reins, 2017, Chapter 2, Heading IV.

Mirror entries in EU (hazardous) waste law. Campos Sánchez-Bordona AG in Verlezza et al. I.a. a useful reminder of the true meaning of precaution.

Update 31 March 2019 the CJEU agrees with its AG. The holder of the waste is required to carry out the relevant internationally recognised tests. Precaution implies that only if after such test which has to be as complete as possible, the presence of hazardous characteristics cannot be clearly established, the hazardous character must be presumed.

Joined Cases C-487/C-489/17 Alfonso Verlezza et al, in which Campos Sánchez-Bordona AG opined  last week, (no version in English available) is one of those rather technical EU environmental law cases which for that reason risks being overlooked by many. This is even more the case in EU waste law. Many of its provisions are subject to criminal law sanctions, hence encouraging defendants to take its application to the most intricate of corners so as to avoid a criminal conviction.

Verlezza et al concerns the implementation by Italy of a notoriously tricky part of EU waste law: the determination of wastes as being ‘hazardous’. Clearly, these wastes are subject to a range of stricter measures than ordinary wastes. Interestingly, while these wastes are more dangerous than ordinary wastes, they are often also more attractive to waste industries: for as secondary raw materials they may have high value (one can think of cartridges, batteries, heavy metals).

Protracted to and fro at the time between the European Commission and the Member States plus Parliament (which I explain in relevant chapter of my Handbook of EU Waste law; which I am pleased to note the AG refers to), eventually led to a regime with two or if one likes three categories: wastes considered per se hazardous; and wastes which may be considered hazardous or not, depending on whether or not they display hazardous properties in the case at issue (hence three categories: hazardous per se; non-hazardous and hazardous in concreto). This latter category are the so-called ‘mirror entries’: wastes originating from the same source which depending on the specifics of the case, may be hazardous or not.

Wastes produced by households (‘domestic waste’) are not considered hazardous. However the AG emphasises correctly that this exemption from the hazardous waste regime (via Article 20 of the waste framework Directive, 2008/98) does not apply to the case at issue, given that the ‘domestic’ wastes concerned have already been mechanically sorted. It is the qualification of the waste residues following sorting that needs to be resolved.

The mirror entries are the result of heated debate between the Institutions. The EC was hesitant to provide a binding list given the need for individual assessment; Council and EP were looking for regulatory certainty. In the end, Member States may (indeed have to)  consider waste as hazardous when the material displays one or more of the hazardous properties listed in Annex to the EU list of waste. This also requires the Member States to issue a procedure which guides this assessment.  It is the specifics of the Italian procedure (producers have to classify specific streams of waste as either hazardous or not; they have to carry out the necessary scientific tests; they are bound by the precautionary principle) which have triggered the case at issue.

At 19 the AG refers to the discussion in Italian scholarship: one part among others on the basis of the precautionary principle defends a reversal of the burden of proof: waste in the mirror entries is considered hazardous unless industry proves its non-hazardous characteristics; the other part proposes that scientific analysis needs to determine hazardousness in each specific case (quoting the sustainable development of the sector in support).

The AG opines that the Italian modus operandi needs to be given the green light, among others referring to the recent April 2018 EC guidance on wastes classification and the criteria defined in the Directive, which render a waste hazardous: producers of waste are perfectly capable indeed in the Directive’s set-up have to assess the hazardous character of the waste and the Italian regulations are a capable way of ensuring this.

The defendants’ ultimate argument that the precautionary principle should allow them to consider waste as hazardous even without such assessment, also fails: scientific assessment is able to determine a substance’s hazardous characteristics.  Defendants’ approach would lead to all mirror entries being defined as hazardous. The Directive’s principle of cost benefit analysis ensures this does not lead to excessive testing-  proportionate testing for properties will do the job. (It may be surprising that the defendants make this argument; but remember: in a criminal procedure all arguments are useful to try and torpedo national law or practice upon which a prosecution is based; without a valid law,, no prosecution).

This latter part of the Opinion, related to the precautionary principle, is a useful reminder to its opponents (who came out in force following this summer’s mutagenesis ruling; for excellent review of which see KJ Garnett here), of the principle’ true meaning.

Geert.

Handbook of EU Waste law, 2nd ed. 2015, OUP, Chapter 2, Heading 2. ff (to which the AG refers).

Micro and nanoplastics pollution. The European Union shifting into gear.

Update 10 January 2019 the final report is out here. Social scientists will be particularly interested in Chapter 3 and Chapter 4, where the report takes a holistic view of risk management.

There are many scientific and legal /regulatory angles to the pollution caused by micro and nanoplastics (MNPs). I was pleased to have been invited to be part of a scoping exercise with the European Commissions Group of Chief Scientific Advisors, following which that Group issued its initial statement early July.

MNPs is an issue where the EU undoubtedly can recognise its regulatory leadership – at the same time appreciating that the challenge is of a truly global nature (many of the worst plastics pollution issues are located in river deltas way outside EU borders). At the scientific level, studies particularly in the marine environment show cause for great concern – but not necessarily easy fixes.

I accepted therefore to be part of the SAPEA Consortium (Science Advice for Policy by European Academies) Working Group on MNPs, which will oversee in first instance the collation of the state of the art: from a regulatory as well as a scientific point of view – and subject to tight deadlines.

Autumn should be interesting.

Geert.

 

Towards an innovation principle: our paper on an industry horse knocking at the EU door.

Update 14 December 2018 Parliament failed to halt references to the innovation principle in Horizon Europe (recital 3 in COM(2018) 435: ‘The promotion of research and innovation activities deemed necessary to help realise Union policy objectives should take into account the innovation principle as put forward in the Commission  Communication of 15 May 2018 ‘A renewed European Agenda for Research and Innovation – Europe’s chance to shape its future’ (COM(2018)306).’ An initial report on the failure is here, I shall have a post soon. Of crucial note is that Commissionner Moedas has emphasised verbatim that the innovation principle is not binding EU law: from the Politico Report: ‘“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.
Moedas continued: “We need an innovation principle as we need a precautionary principle. Both are complimentary.”
Commission officials say the innovation principle does not have the same legal weight as the precautionary principle, which is included in the EU treaties.

Update 12 December 2018. There has been quite a bot of noise around the principle in recent days – see our comments in pieces by Le Monde, Politico, and Follow the Money.

Our paper on the innovation principle, with Kathleen Garnett and Leonie Reins is just out in Law, Innovation and Technology. We discuss how industry has been pushing for the principle to be added as a regulatory driver. Not as a trojan horse: industry knocks politely but firmly at the EU door, it is then simply let in by the European Commission. We discuss the ramifications of such principle and the wider consequences for EU policy making.

Happy reading.

Geert.

(Handbook of) EU Environmental Law (with Dr Reins), 1st ed. 2017, Chapter 2.

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.

Geert.

EU environmental law (with Leonie Reins), Edward Elgar, soft cover edition 2018, p.28 ff.

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.

Geert.

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.

Geert.

 

Show me the data! Bobek AG on food supplements in Noria distribution.

Update 27 April 2017: the CJEU held today, largely along the lines of the AG.

Anyone with an interest in mutual recognition, risk and trade, and the exhaustive effect of EU food law should consult the Opinion of Advocate General Bobek in Case C-672/15 Noria Distribution, which was released last week.

Noria Distribution SARL (‘Noria’) is being prosecuted for having sold in France food supplements containing vitamins and minerals in quantities exceeding maxima set under French law. Noria does not deny doing so. However, it argues in response that those maxima are not valid because they were set in breach of EU law. Noria adds that it produces and sells the same products lawfully in other Member States.

The Advocate General suggests EU law on the issue is not exhaustive. Member States can set their own limits. An issue under discussion in the national proceeding is the origin (national or international) of the science underpinning the limits. The AG justifiably advises that the origin of the data is irrelevant. EU law concern is not about the details of bibliographies. It is rather that restrictions be justified on the basis of solid science demonstrating real risk or at least the inability to exclude risk: whether this is the case is for the national court to determine. The precautionary principle can be invoked by the Member States in setting their limits.

The AG’s approach is very sensible. Without losing himself in lengthy discussion, he reminds the national courts and authorities of the benchmarks for risk management.

Geert.

Is it me, or is it getting chilly? The EC and endocrine disruptors.

Do the newly negotiated EU rules on endocrine disruptors illustrate regulatory chill /the ‘freezing effect’ of international trade law?

The new European Commission proposals on endoctrine disruptors are, of course’ ‘science based’. It has been reported (EurActiv, 12 December 2016 and last consulted by me on 13 December) that publication of the proposals was followed by a closed door meeting (minutes of which were released only after a freedom of information request) between the EC and a select number of countries (US, Canada, Argentina, Brazil and Uruguay on 13 July this year). Discussion centered around the potential WTO incompatibility of parts of the EC proposal, particularly those surrounding the tolerance levels for endocrine disruptors present in imported substances (food and feed in particularly). The EC reportedly are prepared to replace “negligible exposure” with “negligible risk from exposure”. The EC defend the latter, arguing it might even ban more, rather than less imported substances: for even if there is only negligible exposure, that exposure may still be a risk. Opponents suggest that the insertion of a risk approach has sacrified precaution on the altar of science.

A few comments.

Firstly, the report (and potentially even the EC itself) repeats the misleading assertion that the debate concerns either science or precaution. Precaution is NOT unscientific. The very trigger of the precautionary approach is science.

Next, the case is reported at a time a lot of people are getting jittery about the regulatory co-operation mechanisms in free trade agreements such as CETA and TTIP. The meeting and the subsequent EC reaction to our trading partners’ comments, would then represent an example of the ‘freezing effect’ in international trade: with our trading partners flying the flag of WTO incompatibility, the EU would then have caved in to threats of litigation in Geneva. Yet in reality WTO input by fellow WTO Members is at least as old as the WTO itself, indeed it predates it. The 1978 Tokyo Standards Code already obliged the then GATT Contracting Parties to notify their draft standards to the GATT Secretariat. The very point of notification and transparency is that the issues raised are being discussed and may indeed lead to the draft standard being adopted. Changes made to REACH, to name but one example, reflected concerns of fellow WTO Members and REACH can hardly be said to pander to industry’s demands.

However there needs to be one core appreciation in this process: just as notification serves transparency (anyone can consult the TBT notification gateway to review draft measures that have been notified), so too should the process of review after reception of the comments, be conducted in a transparent manner. This clearly has not happened here. By conducting these meetings in private, and by refusing to release the minutes until prompted to do so, EC services have given the impression that there is more than meets the eye. In times where even CETA has not yet been ratified, that is most definitely the wrong approach.

Geert.

 

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