Opinion of the Advocate General — ECLI:EU:C:2023:717
Date: 2023-09-28
Language of the case: Dutch
Subject matter: Agriculture and Fisheries;Approximation of laws;Public health
Procedure: Reference for a preliminary ruling
Origin: Netherlands

Summary  C-309/22 – 1 
Case C-309/22 
Summary of the request for a preliminary ruling pursuant to Article 98(1) of 
the Rules of Procedure of the Court of Justice  
Date lodged: 
11 May 2022 
Referring court: 
College van Beroep voor het bedrijfsleven (Netherlands) 
Date of the decision to refer: 
3 May 2022 
Appellant:  
Pesticide Action Network Europe (PAN Europe) 
Respondent: 
College voor de toelating van gewasbeschermingsmiddelen en 
biociden 
In the presence of: 
Adama Registrations B.V. (Adama) 
  
Subject matter of the main proceedings 
Appeal against a decision of the respondent concerning the authorisation of a plant 
protection product 
Subject matter and legal basis of the request 
The referring court seeks to ascertain, pursuant to subparagraph (b) of the first 
paragraph of Article 267 TFEU, what implications the entry into force of 
Regulation 2018/605 has for ongoing assessment and decision-making processes 
relating to applications for authorisation.  
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SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-309/22 
 
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Questions referred for a preliminary ruling 
1. Does Article 2 of Regulation 2018/605 imply that the competent authority 
must also apply the new criteria for the determination of endocrine disrupting 
properties in the assessment and decision-making process relating to applications 
for authorisation which were still pending on 10 November 2018, also in view of 
Article 29(1)(e) in conjunction with Article 4(3) of Regulation 1107/2009?  
2. If the answer to the first question is in the negative, is it incumbent on the 
competent authority to stay the assessment and decision-making process relating 
to applications for authorisation pending the findings of the European 
Commission on the effects of Regulation 2018/605 on any proceedings pending 
under Regulation 1107/2009, having regard to recital 8 of the preamble to 
Regulation 2018/605?  
3. If the answer to that second question is in the negative, is it sufficient for the 
competent authority to make an assessment solely on the basis of data known at 
the time of the application, even if the scientific and technical knowledge reflected 
therein is no longer current at the time when the contested decision is taken? 
Provisions of European Union law relied on 
– Regulation (EC) No 1107/2009 of the European Parliament and of the Council 
of 21 October 2009 concerning the placing of plant protection products on the 
market and repealing Council Directives 79/117/EEC and 91/414/EEC 
(‘Regulation No 1107/2009’), in particular, Articles 4, 29, 36 and Annex II  
– Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the 
data requirements for plant protection products, in accordance with Regulation 
No 1107/2009 (‘Regulation No 284/2013’), in particular, the Annex, Section 7, 
Part A 
– Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to 
Regulation (EC) No 1107/2009 by setting out scientific criteria for the 
determination of endocrine disrupting properties (‘Regulation 2018/605’), in 
particular, recitals 1 and 8, and Article 2 
– Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 
setting out scientific criteria for the determination of endocrine-disrupting 
properties pursuant to Regulation (EU) No 528/2012 of the European 
Parliament and Council 
– Commission Implementing Regulation (EU) 2021/1449 of 3 September 2021 
amending Implementing Regulation (EU) No 540/2011(‘Implementing 
Regulation 2021/1449’) 
PAN EUROPE 
 
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– Commission Implementing Regulation (EU) 2021/745 of 6 May 2021 
amending Implementation Regulation (EU) No 540/2011 (‘Implementing 
Regulation 2021/745’) 
Provisions of European Union case-law relied on 
– Judgment of 1 October 2019, C-616/17, Blaise and Others, EU:C:2019:800 
Succinct presentation of the facts and procedure in the main proceedings 
1 Pitcher is a fungicide for professional use that consists of a mixture of the active 
substances fludioxonil and folpet and seven co-formulants. The approval of 
fludioxonil is valid until 31 October 2022 (Implementing Regulation 2021/1449). 
The approval of folpet is valid until 31 July 2022 (Executive Regulation 
2021/745). The new renewal applications have not yet been decided.  
2 On 15 September 2015, Adama applied for the authorisation of Pitcher. By 
decision of 4 October 2019 (‘the primary decision’), the respondent granted 
authorisation until 31 July 2021. That authorisation was renewed several times 
pending the reassessment of the active substances at European level, in 
accordance with the new framework for endocrine disruption.  
3 The appellant lodged an objection with the respondent against the primary 
decision. By decision of 2 September 2020 (‘the contested decision’), the 
respondent declared the objection unfounded and upheld the primary decision, 
amending the legal basis of the decision to Article 29 in conjunction with 
Article 36 of Regulation No 1107/2009. The appellant has appealed against that 
decision. 
The essential arguments of the parties in the main proceedings 
4 The appellant argues that the respondent should have refused the application for 
the authorisation of Pitcher because the chronic effects of the combination of the 
active substances and the co-formulants are unknown. More specifically, it is 
unclear what the delayed, cumulative and synergistic effects of the mixture are. 
The respondent failed to verify whether the data provided by the appellant are 
sufficient to conclude, in the present state of scientific and technical knowledge, 
that there is no risk of these health effects. Nor has an assessment of endocrine 
disrupting effects been made, despite this being advisable. The appellant contends 
that it follows from, inter alia, Regulation No 1107/2009, Regulation 
No 284/2013, the judgment in Blaise and Others and the letter of the European 
Commission of 28 October 2019, that all these effects must be taken into account 
in the light of current scientific and technical knowledge.  
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-309/22 
 
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5 At the hearing, the appellant further explained that the respondent should have 
required tests, studies and analyses as evidence of the absence of any chronic 
effects of Pitcher. The respondent should then have assessed this evidence in the 
light of the state of scientific and technical knowledge at the date of the contested 
decision. Fludioxonil is known to have endocrine disrupting properties, but these 
were not assessed by the respondent.  
6 The respondent takes the view that the application dossier for the authorisation of 
Pitcher contains all the necessary information and that the authorisation of Pitcher 
complies with the legal requirements and therefore it sees no reason to require 
Adama to carry out additional testing as regards carcinogenicity and toxicity due 
to prolonged exposure. The respondent made an independent, objective and 
transparent assessment in the light of the state of scientific and technical 
knowledge and the guidance documents available at the time of application. The 
test for carcinogenicity and toxicity due to prolonged exposure is applied in 
assessing the active substances and not in assessing a plant protection product. 
Although no specific testing for delayed adverse effects on carcinogenicity and 
reproductive toxicity was performed during the assessment of Pitcher, those 
effects and the known cumulative effects were implicitly taken into account in the 
substance assessment and the classification of the Pitcher ingredients based on 
Regulation 1272/2008. Furthermore, there is no established methodology for 
assessing synergistic effects at the product level and therefore they could not be 
taken into account. Endocrine disruption is a new data requirement for substance 
approval and therefore this aspect will not be assessed until the reassessment of 
the substances at European level.  
7 At the hearing, the respondent further explained that animal testing is not 
applicable in this case. The calculation model applied in the assessment of the 
cumulative effects of Pitcher showed that the exposure remains within the safe 
limit. The date of the application is decisive for the assessment. The reassessment 
of the active substances will include for the first time an examination of whether 
these substances have endocrine disrupting properties, as follows from 
Article 14(1) of Regulation 1107/2009. It has already been shown that folpet does 
not have any relevant human endocrine disrupting properties. In the case of 
fludioxonil, the reassessment has yet to be completed. The appellant has not put 
forward any concrete evidence that any of the active substances of Pitcher have 
endocrine disrupting properties.  
Succinct presentation of the reasoning in the request for a preliminary ruling  
8 As regards the question of whether the application dossier contains insufficient 
data on the delayed, cumulative and synergistic effects of Pitcher in relation to 
carcinogenicity and reproductive toxicity, the College considers that this point of 
dispute can be resolved without any need to interpret European Union law. In 
short, the referring court considers that the respondent was entitled to assess those 
effects on the basis of the data provided by Adama by the application of a 
PAN EUROPE 
 
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calculation model. The College considers it important that for the assessment of 
those effects of a plant protection product, assessment frameworks are (in part) 
lacking. The appellant has insufficiently substantiated the concrete risks that 
Pitcher could pose and why it would be necessary to carry out tests, such as 
animal studies, at the product level.  
9 As regards the question of whether the respondent should have refused the 
application for authorisation on the ground that the application dossier does not 
contain sufficient data on the endocrine disrupting properties of the active 
substances, the referring court considers it necessary, first of all, to determine 
whether endocrine-disrupting properties must be assessed when an application for 
authorisation of a plant protection product is examined at national level. The 
referring court notes that it has already referred that question to the Court in 
another case (C-310/22). For the purposes of the present case, the referring court 
proceeds on the assumption that endocrine disrupting properties must be assessed 
at national level.  
10 In that regard, the referring court notes that the respondent’s argument that the 
appellant must specifically demonstrate that one of the active substances 
contained in Pitcher is an endocrine disruptor cannot succeed. Article 29(2) of 
Regulation No 1107/2009 states that the appellant must demonstrate that the 
requirements provided for in points (a) to (h) of paragraph 1 are met. 
Paragraph 1(e) provides that a plant protection product must comply with the 
requirements of Article 4(3) in the light of current scientific and technical 
knowledge. It is then sufficient for the appellant, on the basis of the above 
assumption, to state that it has not been demonstrated that, in the light of current 
scientific and technical knowledge, the plant protection product satisfies the 
requirements of Article 4(3).  
11 In that regard, the referring court states that, with effect from 10 November 2018, 
the criteria set out in the Annex to Regulation 2018/605 for the determination of 
endocrine disrupting properties that may cause adverse effects in humans will 
apply, except for procedures where a vote on a draft Regulation has taken place by 
10 November 2018 at the latest. Recital 8 of Regulation 2018/605 states that the 
European Commission will consider the implications for each procedure pending 
under Regulation 1107/2009.  
12 In this context, the referring court wonders whether the entry into force of 
Regulation 2018/605 has any implications for the (ongoing) assessment of the 
application for authorisation submitted by Adama, and, if so, what these may be. 
Pitcher’s application for authorisation was submitted before 10 November 2018, 
and the respondent took a decision thereon after 10 November 2018 (the primary 
decision). Regulation 2018/605 therefore entered into force during the period 
when the application was still pending. By its first question referred for a 
preliminary ruling, the referring court seeks to ascertain whether the respondent 
should have applied the new criteria for determining endocrine disrupting 
properties in accordance with the state of scientific and technical knowledge at the 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-309/22 
 
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time when the contested decision was taken. In that regard, Article 29(1)(e) of 
Regulation 1107/2009 is relevant.  
13 Furthermore, the referring court considers that the preamble to Regulation 
2018/605 suggests a certain urgency to take prompt action and to take into 
account the recent scientific developments. Therefore, in the opinion of the 
referring court, the respondent’s position – that the new criteria for endocrine 
disruption should not be considered until the extension of the approval of the 
active substances – does not appear to be consistent with the purpose of 
Regulation No 1107/2009, which is to ensure a high level of protection of both 
human and animal health and the environment and to improve the functioning of 
the internal market. Moreover, the respondent’s position does not appear to be 
consistent with the precautionary principle on which Regulation No 1107/2009 is 
based. On the other hand, applying the new criteria for endocrine disruption 
introduced by Regulation 2018/605, in the context of an authorisation procedure 
which was already under way at the time of the entry into force of Regulation 
2018/605, appears to better serve the purpose of Regulation No 1107/2009 and the 
precautionary principle. In that regard, the referring court refers to recital 1 to 
Regulation 2018/605.  
14 In addition, by its second question referred for a preliminary ruling, the referring 
court seeks to ascertain whether the respondent was entitled to decide on the 
application for authorisation pending the European Commission’s findings on the 
effects of Regulation 2018/605 on ongoing proceedings. If the respondent was 
entitled to do so, this gives rise to the third and final question referred for a 
preliminary ruling, namely, whether it is sufficient to make an assessment solely 
on the basis of data known at the time of the application, even if the scientific and 
technical knowledge reflected therein is no longer current at the time when the 
contested decision is taken.