Blaise and others: The CJEU on precaution and regulatory approval.

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.

Geert.

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

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.

Limits to calling upon intellectual property to justify non-disclosure of environmental information – The ECJ in Greenpeace and PAN Europe v Commission (glyphosate)

The ECJ yesterday morning held in an important case with respect to the EU’s transparency regime.

Regulation 1049/2001 constitutes the general regime on access to documents held by EU Institutions. Regulation 1367/2006 implements the Aarhus Convention as far as the EU Institutions are concerned. Directive 91/414 is the plant protection Directive. Under the plant protection Directive, Germany had been the Member State with responsibility to report on the acceptability of approving glyphosate. Greenpeace and Pesticide Action Network Europe had requested access to

–        a copy of the draft assessment report issued by Germany, prior to the first inclusion of glyphosate in Annex I to Directive 91/414;

–        a complete list of all tests submitted by the operators seeking the inclusion of glyphosate in Annex I;

–        the full, complete and original test documents supplied by the operators seeking the inclusion of glyphosate in Annex I, in so far as concerns all long-term toxicity tests, all mutagenicity tests, carcinogenicity tests, neurotoxicity tests and all reproduction studies.

The Commission, upon assist by Germany, granted access to the draft report, with the exception of volume 4 thereof, which the German authorities refused to disclose and which includes the complete list of all tests submitted by the operators seeking the first inclusion of glyphosate in Annex I. Germany was of the opinion that the document at issue contained confidential information relating to the intellectual property rights of the operators which had sought the inclusion of glyphosate in Annex I to Directive 91/414, namely the detailed chemical composition of the active substance produced by each of them, detailed information concerning the process by which each of them produced the substance, information on the impurities, the composition of the finished products and the contractual relations between the various operators which had sought the inclusion of glyphosate.

The ECJ noted the important impact of 1367/2006 on the working of the basic Regulation, Regulation 1049/2001: the first sentence of Article 6(1) of Regulation No 1367/2006 lays down a legal presumption that an overriding public interest in disclosure (relevant for the application of exceptions written into Regulation 1049/2001) exists where the information requested relates to emissions into the environment, except where that information concerns an investigation, in particular one concerning possible infringements of EU law. The Court held that accordingly,  the first sentence of Article 6(1) of Regulation No 1367/2006 requires that if the institution concerned receives an application for access to a document, it must disclose it where the information requested relates to emissions into the environment, even if such disclosure is liable to undermine the protection of the commercial interests of a particular natural or legal person, including that person’s intellectual property, within the meaning of Article 4(2), first indent, of Regulation No 1049/2001. (at 38) The Court rejected any attempt by the EC to soften the impact of Article 6(1) of Regulation 1367/2006: ‘in claris non fit interpretatio’, the provision has to be read on its prima facie meaning. Any other application ‘would amount to disapplying a clear and unconditional provision of a European Union regulation, which is not even claimed to be contrary to a superior rule of law.‘ (at 44 in fine)

The Court subsequently at length considered the meaning of ‘environmental information’ and gave this a wide interpretation.

The case is a good illustration of the complex web of transparency requirements and the consistent approach of the ECJ in favour of disclosure.

Geert.

Toxic policy-making? Rotterdam ‘bans’ the use of Roundup

It is being reported (this link in Dutch only however I suspect the international media will pick up on this soon) this morning that the city of Rotterdam has ‘banned’ the use of Roundup (Monsanto’s flagship herbicide). I was not able at this stage to get confirmation of what has actually been decided. My intuition however tells me what was had happened is not so much a ‘ban’ on the use of Round-up on Rotterdam territory. Rather, I imagine, a decision of the local council no longer to use Roundup in keeping pavements weed-free. A procurement or garden management decision, in other words.

The news caught my eye for I have an interest  in the legality of local (or other) bans on the use of products which have otherwise been approved by EU (such as in this case: EU approval of glyphosate) or national authorities. See e.g. here (but with a need to update with the Mickelsson judgment). A true ban on Roundup would certainly raise the prospect of WTO and EU litigation…

Geert.

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