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The Court of Justice of the European Union has recently ruled on the interplay between, on the one hand, freedom of movement and mutual recognition, and, on the other, a high level of environmental and human health protection under Regulation (EC) No 1107/2009 on plant protection products. In its balancing act, the Court of Justice might have tipped the scales entirely in favour of the environment.
On 25 April 2024 the Court of Justice of the European Union (CJEU) delivered an important judgment on the balancing of environmental protection and freedom of movement under of Regulation (EC) No 1107/2009 on plant protection products, namely C-308/22, PAN Europe (Closer).[1]
The case concerned a complaint from the non-profit organization Pesticide Action Network (PAN) Europe against an approval of a plant protection product in the Netherlands. PAN Europe argued that the Dutch authorities did not take into account the latest scientific evidence, which allegedly shows that the product in question had detrimental effects to pollinators. The Dutch authority claimed that it did not have the authority under the Regulation to take such evidence into account.
Under Regulation (EC) No 1107/2009, the EU legislature has sought to harmonise the level of protection in Member States of the environment and human health when placing plant protection products on the market. The Regulation sets out a rather extensive division of responsibilities between Member States and the Commission and between the Member States themselves.
As regards the latter division, the Regulation seeks to improve the functioning of the internal market related to the approval of plant protection products.
As such, the Regulation divides the EU Member States into three zones with fairly similar agricultural conditions. In order to place a plant protection product on the market, a company may apply for authorisation in any of the Member States within the zones, which will then examine the application in close cooperation with other Member States within the same zone. The application must be examined in light of the uniform principles provided for in the Regulation and using guidance documents from the European Commission available at the time of the application.
Once approved, the applicant can then apply for authorisation of the product in other Member States within the same zone, and that Member State shall, according to Article 36(2) of the Regulation “grant or refuse authorisations accordingly on the basis of the conclusions of the assessment of the Member State” that examined the first application within that zone. However, Article 36(3) provides a derogation from this principle “if, due to its specific environmental or agricultural circumstances, [the Member State] has substantiated reasons to consider that the product in question still poses an unacceptable risk”.
The dispute in the main proceedings concerned a product, which had been approved by the Irish authorities based on the latest guidance documents adopted by the European Commission from 2002. In the Netherlands, which is in the same zone as Ireland, the national authorities had approved the product on the basis of the Irish approval, despite more recent scientific evidence allegedly demonstrating a higher risk to pollinators than demonstrated in the 2002 guidance documents.
The referring court referred several questions to the CJEU, but the most fundamental ones are (i) can the Dutch authorities carry out their own scientific assessment deviating from that carried out by the Irish authorities, and (ii) which scientific evidence can the Dutch authorities take into account in such assessment?
In terms of the first question, the CJEU found that a contextual interpretation of Article 36 of the Regulation demonstrates that a Member State may conduct its own scientific assessment. As such, the CJEU notes inter alia that Article 28 of the Regulation expressly states that a plant protection product cannot be placed on the market unless it has been authorized “in accordance with this Regulation”, i.e. including the requirement of not posing an unacceptable risk to the environment and human health. In addition, according to Article 44, the Member State can withdraw an authorisation at any time if the requirements of the Regulation, in the light of current scientific and technical knowledge, are no longer met; meaning that the Member State should also be able to refuse authorisation in the first place on the same grounds.
In terms of the second question, the CJEU finds that the assessment by the Member States cannot be limited to the guidance documents available at the time of the application. Rather, in line with the precautionary principle, the national authorities have a duty to take into account the most reliable scientific data available and the most recent results of international research.
Although it is settled case-law that regulation having an effect on the environment and human health must be interpreted in light of the precautionary principle, the case is nonetheless remarkable, as the CJEU seems to put so much emphasis on environmental protection that it almost does away entirely with the division of power and the formal procedural requirements set out under Regulation (EC) No 1107/2009.[2]
In this regard, it is worth recalling that the objective of the Regulation is twofold. In addition to a high level of environmental and human health protection, recital 9 and 29 of the Regulation sets out that the purpose of the Regulation is to increase the free movement of plant protection products as well as to avoid any duplication of work and to reduce the administrative burden for industry, by laying down harmonised rules for the approval of plant protection products. As such, under the principle of mutual recognition, authorisations granted by one Member State should be accepted by other Member States where agricultural, plant health and environmental (including climatic) conditions are comparable.
In its interpretation of the Regulation, the CJEU refers to recital 24 of the Regulation (as well as its previous case-law) that “the objective of protecting human and animal health and the environment should ‘take priority’ over the objective of improving plant production”. While this may be understandable, it is striking that the CJEU either does not mention, or only mentions in passing, the principles of freedom of movement, mutual recognition and loyal cooperation between the Member States.
This is particularly so, as the principle of mutual trust is a fundamental principle of the EU legal order, and the CJEU has held that that principle requires Member States to consider all the other Member States to be complying with EU law and with the fundamental rights recognised by EU law.[3]
If all Member States within the same zone are to carry out their own independent scientific evaluation regardless of the conclusions from other Member States, it may raise questions as to what extent the improvement of the freedom of movement for plant protection products has been achieved.
The judgment also seems to give rise to some follow-up questions in terms of the scientific evidence, which the national authority must take into account.
Firstly, it is not entirely clear which documents are to be used, as the judgment seems to set out various different criteria. Article 29 of the Regulation, to which the CJEU refers several times in its judgment, sets out that the plant protection product must comply with the Regulation “in the light of current scientific and technical knowledge”. In paragraph 103 of the judgment, the CJEU notes that an authorisation must be challengeable by raising “any scientific or technical knowledge that is relevant, reliable and current”. However, in its answer in paragraph 110, the CJEU refers to the “most reliable scientific and technical data available”.
Secondly, additional guidance may be needed on how to weigh the additional scientific evidence against the assessment made by other Member States and guidance documents adopted by the European Commission.[4] Although this assessment will be left to the national courts, the CJEU seems, in its previous case-law, to have granted a wide margin of discretion under the precautionary principle, and have, in some cases, only applied the prohibition against hypothetical risks or a zero-risk approach as the standard.[5]
It is therefore our expectation that the CJEU’s judgment will give rise to complex questions before national courts.
The CJEU’s judgment is available here. If you have any questions regarding the judgment or the regulation of plant protection products, please feel free to contact us.
[1] On the same day, the CJEU also delivered its judgment in C-309/22 and C-310/22, PAN Europe concerning the division of responsibility between the Member States and the Commission under the same Regulation.
[2] The same result seems to have been reached in C-309/22 and C-310/22, PAN Europe, where the Member States may conduct a scientific risk assessment of active substances, despite the approval of these substances being the responsibility of the European Commission.
[3] Opinion 2/13 of the Court of 18 December 2014, paragraph 191. See also C-359/16, Altun and Others, and C-370/17 and C-37/18, CRPMPAC on the mutual recognition of documents for posted workers.
[4] The CJEU notes in paragraph 75 that national courts may “take into consideration the conclusions of the assessment carried out by the competent Member State”.
[5] See, most recently, T-536/22, PAN Europe v. Commission, paragraph 80.