Ascenza Agro and Afrasa v. European Commission

February 10, 2020
Final judgment
European Union, Luxembourg

Economic stakeholders
Ascenza Agro, Afrasa
European Commission
Antoine Bailleux (for HEAL)

EU court
Chlorpyrifos, Chlorpyrifos-methyl, Insecticid, Organophosphate
Annul Commission Implementing Regulation (EU) 2020/17 of 10 January 2020 concerning the non-renewal of the approval of the active substance chlorpyrifos-methyl.
General Court of Justice of Luxembourg, European Union

October 5, 2023
Rejects in its entirety the claim for annulment lodged by the applicant companies and orders them to pay the costs.

On 4 October 2023, the General Court of the European Union rejected the application to annul the implementing regulation (EU) 2020/17 adopted by the European Commission on 10 January 2020 concerning the non-renewal of the approval of the active substance chlorpyrifos-methyl (CHP-methyl). The case was brought by two manufacturers of plant protection products, the Portuguese company Ascenza Agro and the Spanish company Industrias Afrasa.

CHPmethyl is an active substance used in pesticides to combat harmful organisms and to treat stored cereals and empty warehouses. Like chlorpyrifos, which will also be banned on 10 January 2020, it belongs to a group of chemicals known as organophosphates. In 2005, CHP-methyl was authorised for production, sale and use in the EU for a period of 10 years. Its registration was subsequently extended three times until 2020.

At the same time, since 2017 and until the adoption of the contentious regulation in 2020, several scientific studies have been conducted into the potentially toxic effects of the substance. Spain, the rapporteur Member State (EMR) responsible for assessing the toxicity of the substance, and the European Food Safety Authority (EFSA) have carried out a number of studies and consultations with civil society and independent scientific experts.

Initially, the EMR and EFSA did not identify any genotoxic risk from CHP-methyl. However, on the basis of the available literature on chlorpyrifos, a substance with a similar structure to CHP-methyl, for which existing concerns had been established, the experts concluded that "no reference value could be established for either genotoxicity or developmental neurotoxicity, making it impossible to assess the risk to consumers, operators, workers, bystanders and residents".

After receiving several comments from Ascenza, EFSA finally considered that CHP-methyl was potentially dangerous to human health, so that the criteria for approval of an active substance set out in Article 4 of Regulation (EU) 1107/2009 in terms of protection of human health were not met. The existence of gaps in the scientific documentation and uncertainties was therefore taken into account. On 10 January 2020, the Commission therefore decided not to renew the registration of CHP-methyl.

In order to have the implementing regulation annulled, the applicant companies argued in particular that the Commission had misapplied the precautionary principle (I), and challenged the European authorities' use of the cross-reference and weight-of-evidence method to fill the gaps in the scientific literature regarding the neurotoxic and genotoxic effects of CHP-methyl (II).The European Court of First Instance rejected all of these arguments.

(I) The ECJ recalled that the precautionary principle applies during the risk assessment phase, and not only during the risk management phase, as the applicant companies had argued. Thus, "the authorities responsible for risk assessment may take protective measures where there is uncertainty as to the effects of the substance on human health, 'without having to wait for the reality and seriousness of those risks to be fully demonstrated'". The TEU notes that mere uncertainty as to the presence of a risk is sufficient to apply the principle.

The TEU specifies that when assessing the risks, account must be taken not only of the most reliable scientific data available and the most recent results of international research, but also of the fact that the studies provided by the applicant should not be given predominant weight in all cases. The TEU here enshrines a principle of updating the procedure for assessing the risks of an active substance.

II) In accordance with Regulation (EU) 1907/2006 (REACH Regulation) on the manufacture and use of chemicals, the cross-reference method is "a method whereby the properties of certain substances can be predicted on the basis of existing data relating to other reference substances which are structurally similar to the first substances".

EFSA, which enjoys a wide margin of discretion in the choice of the assessment methods it applies, provided that its assessment is based on scientific criteria, was able to use this method with sufficient scientific reliability to fill the gaps in the data concerning neurotoxicity and genotoxicity. This wide margin of appreciation, which the Commission also enjoys, justifies the European Court's review being limited to manifest errors of assessment, which are not qualified in this case.

The weight-of-evidence approach is detailed in Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures, and recognises that "the properties of certain substances may [...] be predicted on the basis of data from several independent sources of information". As the Court points out, these two methods make it possible to avoid every substance being tested on animals, in line with the objective set out in recital 40 of Regulation (EU) 1107/2009.

The Court of First Instance dismissed the applicants' application for annulment in its entirety and ordered them to pay the costs.