Posts Tagged Precaution

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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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.

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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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FIPA, Tws Automation and Ivan: ECJ confirms the secondary nature of ‘principles’ in EU environmental law

European environmental law principles may not have practical legal force in and of themselves. They are transposed into secondary law. It is their (incorrect) application and interpretation in conjunction with secondary law, which gives rise to citizens and corporations calling upon the principles to support their individual position. Hence despite their trumpeted value as ‘principles’, in the law in practice, individual citizens or corporations need transposition of said principles in secondary law, to argue that such secondary law has infringed the principles.

A clear application of this reality, is the recent ECJ judgment in Case C-534/13, a case with an impossibly long series of applicants and defendants, which for ease of reference I have dubbed FIPA, Tws Automation and Ivan in title of current posting. (After the main protagonists).

The main issue that arose, was whether national (Italian) legislation under which no provision is made for the authorities to require owners of polluted land who have not contributed to that pollution to carry out preventive and remedial measures, and the sole obligation imposed concerns the reimbursement of the measures undertaken by those authorities, is compatible with the ‘polluter pays’ principle, the precautionary principle and the principles that preventive action should be taken and that environmental damage should be rectified at source as a matter of priority.

The ECJ emphasises the role of Directive 2004/35 in this context. Held that the Directive does not hold against such absence. And recalled in line with previous case-law, that the environmental principles of the Treaty ‘do no more than define the general environmental objectives of the European Union, since Article 192 TFEU confers on the European Parliament and the Council of the European Union, acting in accordance with the ordinary legislative procedure, responsibility for deciding what action is to be taken in order to attain those objectives. (…)  Consequently, since Article 191(2) TFEU, which establishes the ‘polluter pays’ principle, is directed at action at EU level, that provision cannot be relied on as such by individuals in order to exclude the application of national legislation — such as that at issue in the main proceedings — in an area covered by environmental policy for which there is no EU legislation adopted on the basis of Article 192 TFEU that specifically covers the situation in question (…) Similarly, the competent environmental authorities cannot rely on Article 191(2) TFEU, in the absence of any national legal basis, for the purposes of imposing preventive and remedial measures.(…)’ (at 39-41)

A sobering conclusion, yet one solidly rooted in legal practice and institutional balance. 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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Thank you for not displaying. Objections to tobacco display ban go up in smoke.

I have previously referred to the display ban case which Philip Morris took to the EFTA Court. I have only just recently stumbled across the eventual holding of the court which had referred the case to Luxembourg. (The Norwegian court held a year after EFTA’s judgment). Not GAVClaw style to report close to 2 years after date of issue: blame the inadequate (read lack of) system by which EFTA and indeed EU Member States report back on their eventual findings in preliminary review.

The District Court had been instructed by the EFTA Court to review whether the display ban actually affects the sale of domestic products and sale of goods from other EEA States equally. If there is de facto equal treatment, the law surfs on Keck & Mithouard’s exception for ‘selling arrangements’: no infringement of the core prohibition on quantitative restrictions to trade in the first place. (See Alberto Alemanno’s analysis of the EFTA ruling for background).

The national court suggested that the EFTA Court had not been entirely clear on how that test had to be constructed: not at any rate, it held, as a market hindrance test: i.e. that new products’ chances of entering the Norwegian tobacco market should be decisive for the question of whether a restriction exists.  It referred inter alia (at p.35 of the copy referred to above) to the fact that the Norwegian Government in its submission to the EFTA Court had suggested that even though such hindrance for new products at the time did not actually exist, it could be expected indeed hoped that this would be the case. The District Court held that in the light of this acknowledgement by the Government, had the EFTA Court found this problematic, it would and should have said so explicitly. (This in some ways might be seen as a risk for the EFTA Court’s tradition, in line with the ECJ’s approach, to practice judicial economy).

The District Court in the end decided to continue the case on the basis of whether national products have a more favourable position due to local habits and customs linked to tobacco use (at p.35): the burden of proof whether the ban actually and not just potentially affects the marketing of imported tobacco products differently than domestic tobacco products lies with PMI, the Court held. That, it said, was not established with clarity: the de facto discriminatory effect of the display ban was found to be too uncertain to be considered a trade barrier.

The Court then somewhat inconsistently (do Norwegian courts practice wide obiter?) did review suitability and proportionality (not needed if Keck & Mithouard applied). Here, without naming the precautionary principle, the Court applies an important consequence often associated with it: the reversal of burden of proof. The Court essentially wanted PMI to show clear evidence for the display ban not being suitable for restricting the consumption of tobacco in Norway, at any rate in the long term (p.48). The Court essentially relies on previous case-law on tobacco advertising and equates suitability of the display ban with relevant studies and case-law on advertising restrictions. This was bound to (although the court took some length to establish it) lead to a finding of suitability.

Finally, as for proportionality proper, the court (with cross-reference i.a. on the effect of these bans elsewhere) did not find less trade restrictive alternatives (within the context of access to information or branding at point of sale).

This judgment just has to be staple fodder for risk classes and the interaction between risk analysis and trade law.

Geert.

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