I. Facts

Glyphosate is an active substance used for the production of a plant protection product. Developed by Monsanto in the 1970s under the name “Roundup”, glyphosate is now the most widely used herbicide for both professional and personal use.Footnote ¹ In December 2017, the European Commission extended its marketing authorisation, which was about to expire, for a period of five years.Footnote ² This renewal is highly controversial because of the potential carcinogenic effect of glyphosate, which is intensely debated in the scientific community. The International Agency for Research on Cancer (IARC, a body of the World Health Organisation) classified glyphosate as “probably carcinogenic”.Footnote ³ Yet, the European Food Safety Authority (EFSA)Footnote ⁴ and the European Chemicals Agency (ECHA)Footnote ⁵ rejected IARC’s conclusions, minimising the danger to humans posed by glyphosate. Moreover, the so-called Monsanto Papers, Monsanto’s internal documents declassified by the US courts in 2017, seem to show that, since 1999, Monsanto was aware of the carcinogenic effect of glyphosate and tried to impede the work of competent scientific bodies by disguising the data proving the danger of this product.Footnote ⁶ According to these documents, Monsanto financed experts to carry out scientific research to defend the non-carcinogenic nature of glyphosate. Moreover, pursuant to the information provided by two newspapers (The Guardian and La Stampa), dozens of pages of the risk assessment report conducted by EFSA in relation to glyphosate are identical to passages in the application submitted by Monsanto to request the authorisation of this product.Footnote ⁷ Taking into account these uncertainties, and based on the precautionary principle, on 15 January 2019, the Tribunal administratif de Lyon (Administrative Court of Lyon, France) set aside the decision authorising the placing on the French market of Roundup Pro 360 containing the active substance glyphosate.Footnote ⁸ Furthermore, on 2 July 2019, Austria became the first European country to ban all glyphosate products on its territory.Footnote ⁹

It is in this context of uncertainties about the harmfulness of glyphosate and doubts about the validity of its evaluation procedure that the Blaise judgment will be analysed.Footnote ¹⁰ In the case at stake, on 27 September 2016 and 1 March 2017, Mr Blaise and 20 other individuals (jointly the Defendants) entered three shops. In two of them, they defaced containers of glyphosate with paint. In the third shop, they used colour and rollers from the shop itself to deface Roundup products and some display cabinets.Footnote ¹¹ Those acts led to criminal proceedings against the Defendants before the tribunal correctionnel de Foix (Criminal Court of Foix, France), on charges of defacing or damaging the property of another, while acting in concert with others.Footnote ¹² Before that Court, the Defendants pleaded the defence of necessity and the precautionary principle, arguing that their actions aimed to alert the shops concerned and their customers to the dangers associated with selling glyphosate without sufficient warnings.Footnote ¹³ The referring court decided to stay proceedings and to refer questions for a preliminary ruling to the Court of Justice of the European Union (CJEU) on the validity of Regulation no 1107/2009 concerning the placing of plant protection products (including glyphosate) in the market.Footnote ¹⁴ If glyphosate-containing products potentially pose risks to human health and the environment, such a finding would deprive the prosecution of its legal foundation.

II. Judgment

As noted by Advocate General Sharpston in her Opinion, the Defendants held glyphosate as an example of what is wrong with Regulation no 1107/2009.Footnote ¹⁵ Although specific EU acts currently affect the use of glyphosate,Footnote ¹⁶ the referred questions do not mention those acts. Instead, the focus is on the overall regulatory architecture established by Regulation no 1107/2009, concerning all plant protection products. The essential issue before the CJEU is, therefore, whether the provisions of Regulation no 1107/2009 are flawed in such a manner as to render the regulation invalid in light of the precautionary principle.Footnote ¹⁷ Given the scientific and technical complexity of the questions surrounding the application of this principle, judicial review by the CJEU is limited to the assessment of whether the provisions of Regulation no 1107/2009 are vitiated by a manifest error of assessment.Footnote ¹⁸

First, the CJEU states that an applicant is bound to identify, when submitting his application for authorisation of a plant protection product, any substance forming part of the composition of that product that corresponds to the criteria set out in Regulation no 1107/2009. Therefore, contrary to what is envisaged by the referring court, an applicant does not have the option of choosing at his discretion which constituent of that product is to be considered to be an active substance for the purposes of the examination of that application.Footnote ¹⁹ It follows that, on this ground, Regulation no 1107/2009 is not vitiated by a manifest error of assessment.Footnote ²⁰

Second, the CJEU examines the question of whether the alleged failure to analyse the effects of a combination of active substances contained in a plant protection product (cocktail effect) is compatible with the precautionary principle. In this regard, the CJEU states that, under Article 4(2) and (3) of Regulation no 1107/2009, the assessment of the potential cocktail effect is inherent in the assessment of any active substance. Consequently, the procedures leading to the authorisation of a plant protection product must necessarily include an assessment not only of the specific effects of the active substances contained in that product but also of the cumulative effects of those substances and their effects combined with other constituents of that product. Regulation no 1107/2009 is, therefore, not vitiated by a manifest error of assessment in that respect.Footnote ²¹

Third, the CJEU considers that the EU legislature sought to control the quality of the tests, studies, and analyses submitted by an applicant under Regulation no 1107/2009.Footnote ²² Moreover, the Member State (the Rapporteur MS) to which an application is submitted and EFSA must undertake an independent, objective and transparent assessment of that application in the light of current scientific and technical knowledge. For that reason, the Rapporteur MS and EFSA must take account of the most reliable scientific data available and the most recent results of international research and not give in all cases preponderant weight to the studies provided by the applicant.Footnote ²³ In the light of the foregoing, it does not appear that Regulation no 1107/2009 is vitiated by a manifest error of assessment in that it provides that the tests, studies and analyses necessary in the procedures for approval of an active substance and/or a plant protection product are to be submitted by the applicant, but does not systematically require that an independent counter-analysis is carried out.Footnote ²⁴

Fourth, the CJEU states that under Article 4(3)(b) and Article 29(1)(e), a plant protection product can be authorised only if it is established that it has no immediate or delayed harmful effect on human health. It follows that a plant protection product cannot be considered to satisfy that condition where it exhibits any long-term carcinogenicity and toxicity.Footnote ²⁵ It is, therefore, the task of the competent authorities, when examining an application for the authorisation of a plant protection product, to verify that the material submitted by the applicant is sufficient to exclude, in the light of current scientific and technical knowledge, the risk that that product exhibits such carcinogenicity or toxicity.Footnote ²⁶ In light of the foregoing, Regulation no 1107/2009 is not vitiated by a manifest error of assessment.

III. Comment

As stressed by Olivier De Schutter, the glyphosate dossier has “a particularly high profile”,Footnote ²⁷ and its authorisation under EU law remains highly controversial. In this context, one might have expected that the Blaise judgment would contribute to shedding some light on the legal questions surrounding the glyphosate saga.Footnote ²⁸ However, this was not the case. The formulation of the questions for preliminary rulings – focusing on the overall regulatory architecture established by Regulation no 1107/2009 – prevented the CJEU from extending its analysis to the core of the questions at stake in the glyphosate saga. From this perspective, the Court conducted a very detailed but rather abstract check of the provisions of Regulation no 1107/2009 in light of the precautionary principle, but was not able to assess the validity, in light of the precautionary principle, of the decision of the Commission to re-authorise glyphosate and the adequacy of Regulation no 1107/2009 to ensure the transparency and independence of the risk assessment conducted by EFSA. To tackle these issues, two different paths could be followed.

From one side, the decision of the Commission to re-authorise glyphosate could be challenged for breach of the precautionary principle. According to an established case law, when applying the precautionary principle, the decision-makers are bound to a duty of care.Footnote ²⁹ For the Court, the duty of care implies the obligation of the decision-makers to analyse carefully and completely all the elements likely to determine their decision,Footnote ³⁰ as well as the obligation to carry out an adequate instruction of the file by gathering the appropriate factual elements.Footnote ³¹ From this perspective, the duty of care is an essential procedural safeguard to guarantee the scientific objectivity of the precautionary measures and to avoid arbitrary decisions.Footnote ³² In the case of 22 November 2017, European Commission/Bilbaína de Alquitranes SA e.a, the CJEU states that, when assessing the toxicity of a product, the Commission shall not limit its assessment solely to the elements expressly referred to in the applicable legislation to the exclusion of any other. By its duty to act diligently, the Commission is required to examine carefully and impartially other factors which, although not expressly referred to by those provisions, are nevertheless relevant.Footnote ³³ Against this backdrop, one might wonder if the Commission, when renewing the authorisation of glyphosate, complied with its duty of care. Indeed, in the implementing Regulation no 2017/2324 of 12 December 2017, no reference has been made to the scientific controversy about the possible carcinogenic effect of glyphosate.Footnote ³⁴ The Commission confines itself to taking into account the scientific opinions of EFSA and ECHA (which negate the carcinogenic nature of glyphosate), without mentioning the scientific input provided by IARC (which establishes the probable carcinogenic nature of glyphosate). If the duty of care implies the obligation of the decision-makers to take into account all the most relevant scientific data available, the Commission should have taken into account the opinion given by IARC to provide a complete picture of the scientific background of the glyphosate dossier. Indeed, according to its duty of care, the Commission is required, in the interests of sound administration, to conduct a complete and impartial examination of the file, so that it has at its disposal when adopting the final decision, the most complete and reliable information possible.Footnote ³⁵ In line with these considerations, in its resolution as of 24 October 2017, the European Parliament stated that the decision of the Commission to re-authorise glyphosate “fails to ensure a high level of protection of both human and animal health and the environment, fails to apply the precautionary principle, and exceeds the implementing powers provided for in Regulation (EC) No 1107/2009”.Footnote ³⁶

From the other side, as underlined by Advocate General Sharpston in her Opinion, “most laws are capable of improvement, and the PPP Regulation [Regulation no 1107/2009] is probably no exception to that general rule”.Footnote ³⁷ In this regard and with the purpose of better ensuring the transparency and independence of the authorisation procedure of pesticides and other products (additives, flavours, enzymes and GMOs) that enter into the food chain, the European Parliament has adopted a new regulation on 17 April 2019.Footnote ³⁸ By 2020, most of the data submitted by the industry to EFSA, as part of the application for the authorisation of a substance or product, will be publicly available. This publication must be made without delay as soon as a marketing authorisation application is considered to be admissible or valid in order to allow the public to verify these evaluations.Footnote ³⁹ Moreover, EFSA shall establish and manage a database containing all the studies commissioned or carried out by business operators to support their application.Footnote ⁴⁰ In addition, in exceptional circumstances of serious controversies or conflicting results, the Commission may request EFSA to commission scientific studies, other than those provided by the industry, with the objective of verifying the scientific evidence used in its risk assessment process.Footnote ⁴¹

To conclude, the Blaise judgment marks a new stage, even if not a definitive one, in the glyphosate saga. On the one hand, it is a new development because the CJEU clarifies that the source of the legal complexity surrounding the glyphosate’s dossier is not to be found in Regulation no 1107/2009. Indeed, the validity of provisions of EU law is to be assessed according to the characteristics of those provisions themselves and cannot depend on the particular circumstances of a given case.Footnote ⁴² Consequently, because concerns relating to glyphosate are not representative of a systemic and fundamental failure undermining Regulation no 1107/2009 they cannot place in doubt the overall integrity of the prior approval system established by that regulation. On the other hand, the Blaise judgment does not solve the questions concerning the validity of the decision of the Commission to re-authorise glyphosate and the suspected lack of transparency and independence of the risk assessment conducted by EFSA. From this perspective, further developments in the two directions indicated above may enable to better seize the core of the glyphosate’s dossier and set the scene for the adoption in 2022 by the European Commission of a new decision on the authorisation of this active substance in Europe.Footnote ⁴³