Posts Tagged Precautionary principle

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

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.

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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.

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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.

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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.

 

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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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Biocides rebuke teaches EC to honour dates, and not to use Impact assessment as an excuse.

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.

Geert.

 

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Not on my soil! The Council of the EU compromise on national vetoes to GMO cultivation.

The Council has published its first-reading position on a draft directive granting member states more flexibility to decide whether or not they wish to cultivate genetically modified organisms(GMOs) on their territory – I had flagged it here before I had an opportunity chance to look at the text. My initial reaction is confirmed however.

Under the text, the possibility would be provided for a Member State to request the Commission to present to the notifier/applicant its demand to adjust the geographical scope of its notification/application to the effect that all or part of the territory of that Member State be excluded from cultivation. The Commission shall facilitate the procedure by presenting the request of the Member State to the notifier/applicant without delay and the notifier/applicant should respond to that request within an established time-limit. In the event of refusal, the Member State may block cultivation on its territory for reasons other than the scientific assessment which will have been carried out by the relevant authorities. (And note that the EC may after refusal also proceed to adjusting geographically the request for authorisation for scientific reasons).

The list of ‘compelling reasons’ which may lead a Member State to refuse cultivation, is non-exhaustively listed as

(a) environmental policy objectives distinct from the elements assessed according to the Directive and to Regulation 1829/2003;  (since those environmental objectives will have been considered in the scientific assessment);

(b) town and country planning;

(c) land use;

(d) socio-economic impacts;

(e) cross-contamination with other products;

(f) agricultural policy objectives; and

(g) public policy.

Those grounds may be invoked individually or in combination, with the exception of the public policy exception (which awkwardly needs to be coupled with one of the other grounds). An authorisation procedure will apply (with no need to apply the transparency Directive, 98/34, concurrently).

An important point to note is that the Directive only applies to growing (‘cultivation’) of GMOs in situ: not to the import, marketing etc. of GMO containing products, food, feed etc. I would not be surprised that in practice this will mean a continuation of industry practice to leave the EU altogether for growing GMOs, focusing its efforts instead on securing authorisation to market. (This regime does not feature the much wider leeway for non-science driven objections).

Today is the Saint’s Day of Saint Ignatius Loyola, founder of the Jesuits. A suitable day to ponder a proposal heavy with risk analysis, regulatory theory,  and trade law implications.

Geert.

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