Opinion of the Advocate General — ECLI:EU:C:2023:716
Date: 2023-09-28
Language of the case: Dutch
Subject matter: Agriculture and Fisheries;Approximation of laws;Public health;Fundamental rights;Charter of Fundamental Rights
Procedure: Reference for a preliminary ruling
Origin: Netherlands

Summary  C-308/22 – 1 
Case C-308/22 
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 
Applicant:  
Pesticide Action Network Europe (PAN Europe) 
Defendant: 
College voor de toelating van gewasbeschermingsmiddelen en 
biociden 
  
Subject matter of the main proceedings 
Action brought against a decision of the defendant concerning the extension of the 
authorisation of a plant protection product 
Subject matter and legal basis of the request 
Interpretation of Article 36 of Regulation No 1107/2009, also in conjunction with 
Article 47 of the Charter; point (b) of the first paragraph of Article 267 TFEU. 
Questions referred for a preliminary ruling 
1. Does the Member State concerned, which decides on the authorisation of a 
plant protection product under Article 36(2) of Regulation 1107/2009, have any 
discretion to depart from the assessment of the zonal rapporteur Member State that 
examined the application under Article 36(1) of Regulation 1107/2009 and, if so, 
what is the margin of that discretion? 
EN 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-308/22 
 
2  
2. If the answer to the first question is that the Member State concerned has no 
or limited discretion, how is the right to an effective remedy under Article 47 of 
the Charter given effect? Is it then possible for the correctness of the zonal 
rapporteur Member State’s assessment to be fully challenged before the national 
court of the Member State concerned? 
3. If the Member State concerned, or the court of that Member State, concludes 
that the zonal rapporteur Member State’s assessment is based on insufficient 
grounds, to what extent is the Member State concerned required to involve the 
zonal rapporteur Member State in preparing an adequately reasoned assessment? 
4. Can the zonal rapporteur Member State confine itself to an assessment based 
exclusively on adopted guidance documents, even if the scientific and technical 
knowledge contained therein is no longer fully up to date? 
5. If the answer to the previous question is in the negative, can the Member 
State carrying out the zonal assessment additionally rely on scientific and 
technical knowledge contained in guidance documents which have already been 
drawn up but not yet adopted, or must the Member State carrying out the zonal 
assessment take account of all scientific and technical knowledge available even 
outside of the guidance documents? 
Provisions of European Union law relied on 
– Charter of Fundamental Rights of the European Union (‘the Charter’), in 
particular Article 47 
– Regulation (EC) No 1107/2009 of the European Parliament and of the Council 
concerning the placing of plant protection products on the market (‘Regulation 
No 1107/2009’), in particular Articles 36, 77 and 79 
– Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing 
Regulation (EC) No 1107/2009 of the European Parliament and of the Council 
as regards uniform principles for evaluation and authorisation of plant 
protection products (‘Regulation No 546/2011’), in particular point 2.5.2.3. 
– Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the 
data requirements for plant protection products, in accordance with Regulation 
(EC) No 1107/2009 (‘Regulation No 284/2013’)  
– EFSA Guidance Document on Terrestrial Ecotoxicology, SANCO/10329/2002 
rev 2, 17 October 2002 (‘the 2002 guidance document’) 
– EFSA Guidance Document on the risk assessment of plant protection products 
on bees, EFSA Journal 2013; 11(7):3295, published on 4 July 2013 (‘the 2013 
guidance document’) 
PAN EUROPE 
 
3 
– EFSA Scientific Opinion on the science behind the development of a risk 
assessment of plant protection products on bees (Apis mellifera, Bombus spp. 
and solitary bees), EFSA Journal 2012;10(5):2668, published on 23 May 2012 
(‘the 2012 scientific opinion’) 
European Union case-law relied on 
– Judgment of 6 May 2021, Bayer CropScience and Bayer v Commission, 
C-499/18, EU:C:2021:367, in particular paragraphs 66 to 70 and 79 to 80 
– Judgment of 1 October 2019, Blaise and Others, C-616/17, EU:C:2019:800, in 
particular paragraph 47 
Succinct presentation of the facts and procedure in the main proceedings 
1 Closer is a plant protection product based on the active substance sulfoxaflor. On 
30 April 2015, Dow lodged an application in the Netherlands for the authorisation 
of Closer to be extended to use in the open cultivation of cabbages and potatoes. It 
also lodged the same application, as regards the central zone (including the 
Netherlands), in Ireland, Austria, Belgium, the Czech Republic, Germany, 
Hungary, Poland, Romania, Slovakia and the United Kingdom. 
2 As the zonal rapporteur Member State, Ireland assessed the application on the 
basis of the 2002 guidance document and completed this assessment in 2016. 
Ireland did not use the 2013 guidance document, which was drawn up by EFSA at 
the request of the European Commission to assess the risks to bees. 
3 On the basis of that assessment, the defendant decided (decision of 5 April 2019) 
to extend the authorisation of Closer to include the requested use, adding a 
restrictive phrase that prohibits application of the product when bees are flying to 
the crop and prevents exposure not only through the flowers of the crop itself, but 
also through flowering weeds in the field. 
4 The applicant lodged an objection against the decision of 5 April 2019. By 
decision of 5 February 2020 (‘the contested decision’), the defendant rejected the 
objection as unfounded. It is against that decision that the applicant has brought 
the present action. 
The essential arguments of the parties in the main proceedings 
5 The applicant claims that Ireland’s assessment, as followed by the defendant, was 
not based on current scientific and technical knowledge, as required by 
Article 29(1)(e) and Article 36(1) of Regulation No 1107/2009. It argues that the 
2002 guidance document is out of date and only deals with acute effects on 
honeybees and not with sublethal effects, chronic effects, exposure through 
weeds, effects on reproduction and effects on bumblebees and solitary bees. Those 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-308/22 
 
4  
effects must also be taken into consideration in the assessment, in accordance with 
point 2.5.2.3. of Regulation No 546/2011. By applying the 2002 guidance 
document, those effects were not taken into account in the Irish assessment, which 
undermines the high level of protection sought by Regulation No 1107/2009. The 
risk assessment should therefore have been based on the 2013 guidance document 
or, in any event, on the new scientific and technical knowledge that had emerged 
since the 2002 guidance document. 
6 The 2002 guidance document does not cover the risks to bumblebees and solitary 
bees, as it erroneously identifies the less sensitive honeybee as an indicator 
species for bumblebees. The assessment did not include harmful effects 
(reproductive problems) of the active substance sulfoxaflor on bumblebees. A risk 
assessment for bumblebees and solitary bees was added to the 2013 guidance 
document. As the 2013 guidance document thus contains new scientific evidence, 
the assessment should have been based on that guidance document. 
7 Unlike the extension of Closer, the approval of the active substance sulfoxaflor in 
2015 was based on the 2013 guidance document. A high risk to bees was 
identified on the basis of the data submitted by Dow. That data was not taken into 
account in the assessment at issue. Had the defendant done so, it would have 
found the same risks. The restriction imposed is insufficient and, moreover, 
inapplicable, impracticable and unenforceable. According to the judgment in 
Bayer CropScience and Bayer v Commission, which dealt with the importance of 
the precautionary principle, further investigation is required before a product can 
be authorised where there is uncertainty as to its effects. 
8 The 2013 guidance document has been available since its publication in 2013, and 
thus at the time of application. This is not altered by the fact that some Member 
States do not wish to apply the 2013 guidance document for political reasons, 
since Regulation No 1107/2009 does not require a majority view of the Member 
States for a guidance document to be applied. It is clear from the judgment in 
Bayer CropScience and Bayer v Commission that the examination must be carried 
out on the basis of scientific and technical knowledge, regardless of the source or 
document from which it comes. 
9 The defendant submits that, in the light of Article 36 of Regulation 
No 1107/2009, the zonal rapporteur Member State was required to carry out the 
assessment on the basis of the 2002 guidance document because legal certainty 
requires that the assessment be carried out on the basis of the assessment 
framework at the time of application. Therefore, the risk assessment for bees was 
carried out using the 2002 guidance document and did not take into account the 
new scientific and technical knowledge that emerged subsequently. 
10 At the time of application, the 2013 guidance document was not yet available 
within the meaning of Article 36(1) of Regulation No 1107/2009 because it had 
not yet been adopted by the European Commission. 
PAN EUROPE 
 
5 
11 Furthermore, in this case, it does not matter whether the assessment was based on 
the 2002 guidance document or the 2013 guidance document, except possibly with 
regard to off-field exposure. Sublethal effects were also not taken into account in 
the 2013 guidance document due to a lack of clarity as to the impact of those 
effects on the survival of the population, except for potential effects on brood 
care. 
12 However, the dossier does contain data on chronic effects, in the form of semi-
field tests, which confirm that exposure to sulfoxaflor or to recently treated 
flowers is harmful to bees. As these semi-field tests are not suitable for 
determining the effect on bee brood development, they were not capable of 
eliminating the potential risk to bee brood and an effect on bee brood in the event 
of exposure cannot be ruled out. 
13 Consequently, restrictions on use were imposed, using the honeybee as an 
indicator species on the basis of the 2002 guidance document. The restrictive 
phrases for the honeybee also eliminate a large part of the exposure of other bee 
species as the dossier on sulfoxaflor shows that bumblebees are no more sensitive 
than honeybees. The restrictive phrase was adopted at European level and is 
considered to be generally applicable, practicable and enforceable. 
14 It was not possible to make use of the assessment for the approval of the active 
substance sulfoxaflor as it related to outdoor crops other than those for which the 
extension of the authorisation of Closer was applied for. 
Succinct presentation of the reasoning in the request for a preliminary ruling 
15 The referring court is uncertain whether and to what extent the Member State 
concerned is entitled or obliged to examine independently whether the zonal 
rapporteur Member State carried out the assessment in accordance with 
Article 36(1) of Regulation No 1107/2009, and whether and to what extent the 
referring court must subsequently review the defendant’s decision on 
authorisation in the light of those requirements, in so far as that is appropriate for 
reasons invoked against that decision. Article 36(2) of Regulation No 1107/2009 
seems to maintain that the Member States concerned grant or refuse authorisations 
on the basis of the conclusions of the zonal rapporteur Member State examining 
the application as provided for in Articles 31 and 32 of Regulation No 1107/2009. 
The wording of that provision seems to imply that the Member States concerned 
are required to adopt the conclusions of the zonal rapporteur Member State in 
their authorisation decisions. Although paragraph 3 provides that, by way of 
derogation from paragraph 2, appropriate conditions with respect to the 
requirements referred to in Article 31(3) and (4) of Regulation No 1107/2009 and 
other risk mitigation measures may be imposed, these must derive from specific 
conditions of use. However, that is not the case here. The referring court is 
uncertain whether the exception provided for in paragraph 3 is so far-reaching that 
it confers on the Member State concerned the power or the obligation to review 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-308/22 
 
6  
the conclusions of the zonal rapporteur Member State on the basis of an 
examination which must satisfy the same requirements, set out in Article 36(1) of 
Regulation No 1107/2009, as those which are applicable to the zonal rapporteur 
Member State examining the application on the basis of that provision. 
16 If the defendant does not have that power and is required to adopt the conclusions 
of the zonal rapporteur Member State on the application, the question arises as to 
whether parties such as the applicant in the Member States concerned can avail 
themselves of the right to an effective remedy under Article 47 of the Charter to 
challenge the correctness of the assessment by the zonal rapporteur Member State 
in the context of the authorisation of the relevant plant protection product in the 
Member State concerned. Furthermore, if Article 36 of Regulation No 1107/2009 
were to be interpreted as requiring the defendant to consider the assessment of the 
zonal reporting Member State as a fait accompli, the referring court is uncertain 
whether such an interpretation is consistent with the precautionary principle, 
which Member States must apply where there is scientific uncertainty as to the 
risks to human and animal health or to the environment posed by the plant 
protection products to be authorised in their territory. It is clear from the judgment 
in Blaise and Others that this principle requires a comprehensive assessment of 
the risk to health based on the most reliable scientific data and the most recent 
results of international research. By virtue of the right to an effective remedy and 
in the light of the precautionary principle, the referring court considers that it is 
not necessary to automatically adopt the assessment of the zonal rapporteur 
Member State. The question then arises as to the consequences of a finding that 
the zonal rapporteur Member State’s assessment is not based on sufficient 
grounds. Must the zonal rapporteur Member State, which is not a party to the 
proceedings, review the assessment, or is it then for the Member State concerned, 
which has received the application for authorisation, to arrive at a new assessment 
itself, with or without consultation with the zonal rapporteur Member State? 
17 If the defendant, as the Member State concerned, did have the power to carry out 
its own assessment on the basis of an examination that must meet the 
requirements set out in Article 36(1) of Regulation No 1107/2009, the question 
would arise as to whether this would unduly infringe the main rule laid down in 
Article 36(2) of Regulation No 1107/2009 and the principles of uniformity and 
harmonisation on which it is based. 
18 In these proceedings, the question also arose as to how the phrase ‘current 
scientific and technical knowledge using guidance documents available at the time 
of application’ should be interpreted. 
19 The first point is the interpretation of the term ‘available’. The defendant argues 
that this requires the guidance document to have been adopted by the European 
Commission and refers to the provisions of Regulation No 1107/2009 concerning 
the drafting of guidance documents, from which it follows that the 2013 guidance 
document is not yet part of the assessment framework adopted by Europe. The 
applicant, on the other hand, argues that it is sufficient that this guidance 
PAN EUROPE 
 
7 
document has been published. Regulation No 1107/2009 does not provide a clear 
answer to the question. 
20 Secondly, it is not possible, on the basis of the wording of Article 36(1) of 
Regulation No 1107/2009, to determine beyond doubt whether the obligation to 
carry out the assessment in the light of current scientific and technical knowledge 
can be deemed to be separate from the obligation to carry out the assessment 
‘using guidance documents available at the time of application’. On the one hand, 
it can be argued that current scientific and technical knowledge can be ascertained 
both from guidance documents (whether adopted or not) and from scientific 
studies and publications which have not (yet) been incorporated in adopted 
guidance documents. This corresponds to the requirement for authorisation, laid 
down in Article 29(1)(e) of Regulation No 1107/2009, that, in the light of current 
scientific and technical knowledge, the plant protection product must comply with 
the requirements provided for in Article 4(3) of Regulation No 1107/2009. The 
guidance document is not mentioned here. The precautionary principle also 
supports such an interpretation. The referring court is uncertain whether the 
judgment in Bayer CropScience and Bayer v Commission also indicates that the 
assessment must be based on any new knowledge, in so far as it is scientific or 
technical, regardless of the source or document from which it comes. On the other 
hand, the referring court refers to the position of the defendant, which argues that 
the use of guidance documents is always necessary for reasons of legal certainty. 
21 The answer to the second question is relevant in so far as applying the 2013 
guidance document could lead to a different assessment from that resulting from 
applying the 2002 guidance document.