Criminal proceedings v. Mathieu Blaise and Others

October 26, 2017
Final judgment
European Union, Luxembourg

Justice, Economic stakeholders
Public Prosecutor of Foix, Espace Emeraude
Environmental NGOs, Individual
Guillaume Tumerelle

EU court
Preliminary question
Herbicide, Glyphosate, Roundup
Is Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market compatible with the precautionary principle?
Court of Justice of the European Union of Luxembourg, European Union

October 1, 2019
An examination of the questions referred for a preliminary ruling has revealed nothing capable of affecting the validity of the EC Regulation concerning the placing of plant protection products on the market.

On October 1, 2019, the Court of Justice of the European Union answered the 4 questions referred to it by the Foix Criminal Court concerning the validity of Regulation No 1107/2009 concerning the placing of plant protection products on the market with regard to the precautionary principle.

The Foix Court was called upon to judge acts of damage and destruction of cans of weedkiller containing glyphosate in stores. Before the court, the defendants, voluntary Anti-GMO Reapers, invoked the state of necessity and the precautionary principle, arguing that the aim of their actions had been to alert the shops concerned and their customers to the dangers associated with selling, without sufficient warnings, weed killers containing glyphosate, to prevent such sales, and to protect public health and their own health (point 28). In order to give a ruling on whether that argument is well founded, the referring court was uncertain whether the EU legislation is capable of fully ensuring the protection of the human population and considered therefore, that a ruling on the validity of Regulation No 1107/2009 in the light of precautionary principle was required (point 29). Against this backdrop, the Criminal Court of Foix questioned the Court on four points.

(I) Firstly, whether Regulation No 1107/2009 complies with the precautionary principle when it fails to define precisely what an active substance is, leaving it up to the petitioner to choose what he calls an active substance in his product, and allowing him to focus his entire application dossier on a single substance, even though his marketed finished product includes several. The Court considers that the choices made by the Union legislature are not vitiated by a manifest error of assessment in this respect, since it is for the competent authorities of the Member States to ensure that the obligation to identify the active substances contained in the plant protection product covered by an application for authorization has been complied with by the applicant (point 59), and that in any event, the holder of an authorization for a plant protection product who has not, in his application for authorization, mentioned all the active substances contained therein, would be liable, under Article 44(3)(a) and (b) of the said Regulation, to have his authorization withdrawn (point 60).

(II) Secondly, whether the regulation complies with the precautionary principle where it takes no account of the cumulative effects of pesticide ingredients. The Court ruled that the Union legislature had required account to be taken of the potential cumulative effects of the various components of a plant protection product (active substances, safeners, synergists, co-formulants) both during the procedure for the approval of active substances and that for the authorization of plant protection products (paragraph 65).

(III) Furthermore, on the question of whether the precautionary principle and the impartiality of the marketing authorization are ensured when the tests, analyses and assessments necessary for the examination of the dossier are carried out solely by the petitioners, who may be biased in their presentation, without any independent counter-analysis and without the publication of the authorization application reports under cover of protection of industrial secrecy, the Court ruled in two stages that there was no manifest error of assessment.

(a) First, as regards the fact that the tests, studies and analyses required for the approval of an active substance and the authorization of a plant protection product are supplied by the applicant, without any independent counter-analysis, the Court rules that there is no manifest error of assessment, since on the one hand, the competent authorities cannot rely, with a view to ascertaining the absence of harmful effects of a plant protection product, on tests, analyses and studies for which the applicant has not provided evidence showing that they were carried out by a reliable institution on the basis of methods in accordance with accepted scientific principles (point 91), and secondly, the Member State to which an application is submitted must carry out an independent, objective and transparent assessment of the application in the light of current scientific and technical knowledge, while the Authority must take account of the current state of scientific and technical knowledge (point 88), which means that they are obliged to take account of relevant factors other than the tests, tests, analyses and studies produced by the applicant which would contradict the latter (point 93) and to take account of the most reliable scientific data available as well as the most recent results of international research and not in all cases to give predominant weight to the studies supplied by the applicant (point 94)

(b) Turning to the question of the public nature of applications for marketing authorizations for pesticides, the Court first acknowledges that "increasing the transparency of those procedures is likely to enable an even better assessment of the risk to health resulting from the use of a plant protection product" (paragraph 102). It also points out that the exception deriving from Directive 2003/04/EC on public access to environmental information, according to which "Member States may not provide for a request for access concerning information on emissions into the environment to be refused on grounds relating to the protection of the confidentiality of commercial or industrial information", applies to studies intended to assess the harmfulness of the use of a plant protection product or the presence in the environment of residues following the application of that product (points 107 and 108).

(IV) Finally, on the compatibility with the precautionary principle of the alleged exemption from carcinogenicity and toxicity studies for the purposes of the authorization procedure, the Court acknowledges that Regulation No 1107/2009 "does not prescribe in detail the nature of the tests, analyses and studies to which plant protection products must be subject if they are to obtain authorisation." (point 111). However, the Court, interpreting the Regulation in accordance with Articles 4(3)(b) and 29(1)(e), states that a plant protection product cannot be regarded as satisfying the condition of having no immediate or delayed harmful effect on human health if it exhibits any form of carcinogenicity or long-term toxicity. It thus concludes that "It is therefore the task of the competent authorities, when examining an application for the authorization of a plant protection product, to verify that the material submitted by the applicant, and primarily the tests, analyses and studies of the product, is sufficient to exclude, in the light of current scientific and technical knowledge, the risk that that product exhibits such carcinogenicity or toxicity." (point 116).