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