Opinion of the Advocate General — ECLI:EU:C:2022:650
Date: 2022-09-08
Language of the case: French
Subject matter: Agriculture and Fisheries;Approximation of laws;Public health
Procedure: Reference for a preliminary ruling
Origin: Belgium

Summary C-162/21 – 1 
Case C-162/21 
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 March 2021 
Referring court:  
Conseil d’État (Belgium) 
Date of the decision to refer:  
16 February 2021 
Applicants:  
Pesticide Action Network Europe ASBL 
Nature et Progrès Belgique ASBL 
TN 
Defendant:  
État belge 
  
I. Subject matter and facts of the dispute: 
1 Neonicotinoids are insecticide substances which are extensively used in 
conventional agriculture, in particular through increasing use of the seed coating 
technique: instead of being sprayed on vegetation, they are preventively applied to 
seeds before sowing. 
2 Thiamethoxam and clothianidin are molecules in the neonicotinoid class which 
are the active substance in several plant protection products. 
3 Initially approved by the European Commission, those two active substances were 
subsequently severely restricted, in particular in the most recent Implementing 
Regulations 2018/784 (‘clothianidin’) and 2018/785 (‘thiamethoxam’) of 29 May 
2018, which prohibit their use ‘except in permanent greenhouses’. Those 
implementing regulations also prohibited, as of 19 December 2018, the placing on 
the market and use of seeds treated with plant protection products containing 
EN 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-162/21 
 
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clothianidin or thiamethoxam, except in relation to crop production in permanent 
greenhouses.  
4 In autumn 2018, the État belge (Belgian State) nonetheless granted six marketing 
authorisations for plant protection products based on clothianidin (the insecticide 
‘Poncho Beta’) and thiamethoxam (the insecticides ‘Cruiser’ and ‘Cruiser 600 
FS’), for the treatment of seeds of certain crops, including beet, and the sowing of 
those seeds in the field, during the spring of 2019 essentially.  
5 The applicants are, on the one hand, associations campaigning against pesticides 
and promoting biodiversity and, on the other hand, a beekeeper. They claim that 
numerous scientific studies have shown that the use of neonicotinoids, and in 
particular thiamethoxam and clothianidin, entails significant risks to certain 
animals other than the targeted pests, in particular to bees, bumble-bees and other 
foraging insects. They argue, inter alia, that the European Food Safety Authority 
(EFSA) considers, first, that the use of seeds coated with products containing 
thiamethoxam poses a high risk to honeybees and bumble-bees, on account of the 
persistence of those substances in crops grown after that produced from those 
seeds, and, secondly, that it has not been demonstrated that the use of those seed 
poses only a low risk to solitary bees, with the result that, in accordance with the 
precautionary principle, a high risk must be presumed. According to the 
applicants, that authority draws the same conclusion as regards products 
containing clothianidin. 
6 The applicants complain that the authorisations granted by the Belgian State 
extend the marketing of treated seeds and their use in the field, which have been 
prohibited since 19 December 2018, and fear that those authorisations may be 
renewed for many years. In the applicants’ view, the Belgian State is wrong to 
seek to justify those authorisations under the derogation provided for in Article 53 
of Regulation No 1107/2009. By application of 21 January 2019, they therefore 
brought an action before the Conseil d’État (Council of State), seeking annulment 
of those authorisations based on an infringement of EU law, and requested their 
immediate suspension.  
7 The Belgian State emphasises that the products in question have been approved 
and used for many years and that their use has been restricted to greenhouse 
cultivation only since September 2018. Their conditions of use ensure that they do 
not pose an unacceptable risk to honey bees and require, in general, that the 
cultivation of bee-attractive plants be avoided for five years following the harvest 
resulting from the sowing of the treated seeds. Moreover, only crops harvested 
before flowering are grown from those seeds, thereby making it possible to avoid 
any contact between bees and plants. According to the Belgian State, the 
applicants have failed to demonstrate the relevance of the studies on which they 
rely and have not provided any evidence to justify the sudden and absolute 
prohibition of the use of those products as provided for by the contested 
authorisations. 
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8 The ASBL (non-profit-making association) Confédération des Betteraviers Belges 
(‘the CBB’) represents approximately 8 200 Belgian sugar beet growers. The 
public limited companies Isera & Scaldis Sugar and Raffinerie Tirlemontoise are 
the two sole members of the ASBL Société générale des fabricants de sucre de 
Belgique (‘SUBEL’), which represents the interests of sugar producers. The 
public limited company Sesvanderhave submitted two applications for 
authorisation to use the insecticides in question. These parties intervened in 
support of the form of order sought by the Belgian State. 
9 The CBB argues that the annulment of the contested measures would cause a 
significant loss of income for the farmers which it represents. SUBEL argues that 
the annulment of those measures would lead in the short term to a loss of 
profitability for sugar beet factories. Both take the view that the annulment of 
those measures could, in the long term, result in the closure of (a part of) the sugar 
industry in Belgium. 
10 By judgment of 5 June 2019, the Conseil d’État rejected the request for 
suspension which accompanied the action for annulment.  
11 By judgment of 16 February 2021, the Conseil d’État, referring expressly to the 
account of the facts set out in the first judgment, asked the Court of Justice to give 
a preliminary ruling in the present case. 
II. European Union law  
The Charter of Fundamental Rights of the European Union 
12 Article 35 of the Charter of Fundamental Rights of the European Union (‘the 
Charter’), 1 entitled ‘Health care’, provides: 
‘Everyone has the right of access to preventive health care and the right to 
benefit from medical treatment under the conditions established by national 
laws and practices. A high level of human health protection shall be ensured 
in the definition and implementation of all Union policies and activities.’ 
13 Under Article 37 thereof, entitled ‘Environmental protection’: 
‘A high level of environmental protection and the improvement of the 
quality of the environment must be integrated into the policies of the Union 
and ensured in accordance with the principle of sustainable development.’ 
 
1 OJ 2007 C 303, p. 1. 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-162/21 
 
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Directive 2009/128/EC of the European Parliament and of the Council of 
21 October 2009 establishing a framework for Community action to achieve the 
sustainable use of pesticides 
14 Article 14(1) of Directive 2009/128, 2 entitled ‘Integrated pest management’, 
provides: 
‘1. Member States shall take all necessary measures to promote low 
pesticide-input pest management, giving wherever possible priority to non-
chemical methods, so that professional users of pesticides switch to practices 
and products with the lowest risk to human health and the environment 
among those available for the same pest problem. …’ 
Regulation 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 
15 Article 2 of Regulation No 1107/2009 defines its scope: 
‘1. This Regulation shall apply to products, in the form in which they are 
supplied to the user, consisting of or containing active substances, safeners 
or synergists, and intended for one of the following uses: 
(a) protecting plants or plant products against all harmful organisms or 
preventing the action of such organisms, unless the main purpose of 
these products is considered to be for reasons of hygiene rather than 
for the protection of plants or plant products; 
(b) influencing the life processes of plants, such as substances influencing 
their growth, other than as a nutrient or a plant biostimulant; 
(c) preserving plant products, in so far as such substances or products are 
not subject to special Community provisions on preservatives; 
(d) destroying undesired plants or parts of plants, except algae unless the 
products are applied on soil or water to protect plants; 
(e) checking or preventing undesired growth of plants, except algae unless 
the products are applied on soil or water to protect plants. 
These products are referred to as “plant protection products”.’ 
16 Article 3 sets out the definitions for the purposes of the regulation, inter alia the 
definition of ‘plants’, which means ‘live plants and live parts of plants, including 
fresh fruit, vegetables and seeds’. 
 
2 OJ 2009 L 309, p. 71. 
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17 Article 4 sets out the approval criteria for active substances:  
‘1. An active substance shall be approved in accordance with Annex II if it 
may be expected, in the light of current scientific and technical knowledge, 
that, taking into account the approval criteria set out in points 2 and 3 of that 
Annex, plant protection products containing that active substance meet the 
requirements provided for in paragraphs 2 and 3. 
… 
3. A plant protection product, consequent on application consistent with 
good plant protection practice and having regard to realistic conditions of 
use, shall meet the following requirements: 
(a) it shall be sufficiently effective; 
(b) it shall have no immediate or delayed harmful effect on human health, 
including that of vulnerable groups, or animal health, directly or 
through drinking water (taking into account substances resulting from 
water treatment), food, feed or air, or consequences in the workplace 
or through other indirect effects, taking into account known cumulative 
and synergistic effects where the scientific methods accepted by the 
Authority to assess such effects are available; or on groundwater; 
(c) it shall not have any unacceptable effects on plants or plant products; 
(d) it shall not cause unnecessary suffering and pain to vertebrates to be 
controlled; 
(e) it shall have no unacceptable effects on the environment, having 
particular regard to the following considerations where the scientific 
methods accepted by the Authority to assess such effects are available: 
(i) its fate and distribution in the environment, particularly 
contamination of surface waters, including estuarine and coastal 
waters, groundwater, air and soil taking into account locations 
distant from its use following long-range environmental 
transportation; 
(ii) its impact on non-target species, including on the ongoing 
behaviour of those species; 
(iii) its impact on biodiversity and the ecosystem.’ 
18 In accordance with Article 28(1): 
‘1. A plant protection product shall not be placed on the market or used 
unless it has been authorised in the Member State concerned in accordance 
with this Regulation.’ 
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19 According to Article 29(1)(a):  
‘1. Without prejudice to Article 50 a plant protection product shall only be 
authorised where following the uniform principles referred to in paragraph 6 
it complies with the following requirements: 
(a) its active substances, safeners and synergists have been approved …’. 
20 Article 53 (‘Emergency situations in plant protection’) provides, in paragraphs 1 
and 4 thereof: 
‘1. By way of derogation from Article 28, in special circumstances a 
Member State may authorise, for a period not exceeding 120 days, the 
placing on the market of plant protection products, for limited and controlled 
use, where such a measure appears necessary because of a danger which 
cannot be contained by any other reasonable means. 
… 
4. Paragraphs 1 to 3 shall not apply to plant protection products containing 
or composed of genetically modified organisms unless such release has been 
accepted in accordance with Directive 2001/18/EC.’ 
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 
implementing Regulation (EC) No 1107/2009 of the European Parliament and 
of the Council as regards the list of approved active substances, as amended by 
Commission Implementing Regulations (EU) 2018/784 and (EU) 2018/785 
21 Article 1 of Regulation No 540/2011, 3 as amended by Implementing Regulations 
(EU) 2018/784 4 and (EU) 2018/785, 5 provides: 
‘The active substances as set out in the Annex to this Regulation shall be 
deemed to have been approved under Regulation (EC) No 1107/2009.’ 
22 Part A of entry No 121 of the Annex to that regulation provides that ‘only uses [of 
clothianidin] as insecticide, in permanent greenhouses or for the treatment of 
seeds intended to be used only in permanent greenhouses, may be authorised. The 
resulting crop must stay within a permanent greenhouse during its entire life 
cycle.’ 
 
3 OJ 2011 L 153, p. 1. 
4 Implementing Regulation of 29 May 2018, amending Implementing Regulation (EU) 
No 540/2011 as regards the conditions of approval of the active substance clothianidin (OJ 2018 
L 132, p. 35). 
5 Implementing Regulation of 29 May 2018, amending Implementing Regulation (EU) 
No 540/2011 as regards the conditions of approval of the active substance thiamethoxam (OJ 
2018 L 132, p. 40). 
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23 Part A of entry No 140 of that annex places identical restrictions on the use of 
thiamethoxam. 
III. Arguments of the parties: 
24 The applicants complain that the contested decisions authorise the placing on the 
market of thiamethoxam or clothianidin for use in the field, although EU law 
prohibits the use of those substances in outdoor crops. 
25 They rely on a single plea, put forward in three parts, alleging, in essence, 
infringement of the Charter, Directive 2009/128, Regulation No 1107/2009 and 
Implementing Regulation No 540/2011. 
First part of the single plea 
Position of the applicants 
26 The applicants take the view that the scope of Article 53 of Regulation 
No 1107/2009 does not include the placing on the market or sowing in the field of 
seeds treated with the substances in question. They base that conclusion on the 
following arguments: 
– The wording of Article 53 limits its scope to ‘the placing on the market of 
plant protection products’. 
– Article 53 derogates from Article 28, concerning the placing on the market 
and use of plant protection products, but not from Article 49, concerning the 
placing on the market and use of treated seeds. 
– Article 53 is intended to allow Member States to respond urgently to the 
occurrence of pests which may cause serious damage. The typical response 
is to spray affected plants or treat the soil around them. The treatment of 
seeds before they have even been sowed, and thus before any danger arises, 
is a preventive measure and not an emergency response measure. 
– Recital 13 of Implementing Regulation 2018/784 and of Implementing 
Regulation 2018/785 states that ‘taking into account the risks for bees from 
treated seeds, the placing on the market and the use of seeds treated with 
plant protection products containing clothianidin [or thiamethoxam] should 
be subject to the same restrictions as the use of clothianidin [and 
thiamethoxam].’ That need to align the legal regime governing seed use with 
the legal regime governing use of active substances shows that there are two 
separate regimes, as is confirmed by the legal basis for those regulations, 
which includes not only Article 21(3) of Regulation No 1107/2009, but also 
Article 49(2) thereof. 
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– The EU legislature laid down provisions expressly covering treated seeds 
because it was mindful of their specific nature. That legislative choice 
confirms that Article 53 does not apply to treated seeds, which are not a 
‘plant protection product’ but ‘plants’ within the meaning of Article 3. 
27 As to the remainder, the applicants take the view that the following elements are 
not relevant to the analysis:  
– Article 53(4), on the ground that treated seeds are not plant protection 
products containing GMOs and fall outside the scope of Article 53 without 
the need for any express derogation. 
– The practice of other Member States which have already used Article 53 to 
authorise the treatment and sowing of coated seeds. 
– The claim that the Commission has indirectly endorsed that practice or is 
about to endorse it expressly, on the ground that the Commission has no 
competence to give a definitive interpretation of EU law. 
28 In the alternative, the applicants request that the Conseil d’État refer a question to 
the Court for a preliminary ruling, to determine whether Article 53 allows a 
Member State to grant an authorisation for the placing on the market and the 
sowing of seeds coated with plant protection products. 
Position of the Belgian State 
29 The Belgian State takes the view that Article 53 of Regulation No 1107/2009 
allows the derogation to be applied to treated seeds, since paragraph 4 thereof 
excludes only products containing GMOs. That interpretation, which is also that 
of the Commission, is consistent with the practice of several Member States which 
have applied Article 53 to seed treatment and to sowing. 
30 In the alternative, it requests that the Conseil d’État refer a question to the Court 
for a preliminary ruling, to determine whether Article 53 allows a Member State 
to grant an authorisation for the treatment of seeds with plant protection products 
or for the sale or sowing of those seeds, where such a measure appears necessary 
because of a danger which cannot be contained by any other reasonable means. 
Position of the interveners 
31 The CBB notes that the placing on the market of a plant protection product under 
Article 53 of Regulation No 1107/2009 necessarily covers its use. As Article 53 
does not distinguish between the various possible uses, it applies both to the 
treatment of seeds with the product and to their marketing. The CBB bases that 
conclusion on the following arguments: 
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– The concept of ‘danger’ set out in Article 53 necessarily implies that a plant 
protection product can be used to prevent, through the use of treated seeds, a 
real threat from arising. Otherwise, that provision would be meaningless, 
since it would be necessary to wait until crops are attacked before requesting 
a derogation. 
– Article 53(4) provides that plant protection products containing GMOs 
cannot benefit from the derogation. The EU legislature therefore intended 
that other non-excluded products would be able to benefit from it. 
32 The CBB also disputes that the EU legislature intended to make treated seeds 
subject to a specific legal regime, not covered by Article 53. It relies on recital 33 
of the regulation and also argues that Article 49 and Article 53 are not part of the 
same subsection of the regulation. Article 49 allows a Member State to impose 
prohibitions, whereas Article 53 allows it to issue authorisations. The explanation 
for their coexistence lies in a difference in material scope and not the deliberate 
introduction of separate legal regimes relating to the same subject matter (namely 
marketing authorisations), but not the same object (on the one hand, treated seeds 
under Article 49 and, on the other hand, plant protection products under 
Article 53).  
33 The other interveners refer, in essence, to the arguments put forward by the 
Belgian State. 
Second part of the single plea 
Position of the applicants 
34 The applicants take the view that the derogation provided for in Article 53 of 
Regulation No 1107/2009 does not permit the authorisation of uses of plant 
protection products which are expressly prohibited by the European Union. In 
cases of emergency, that derogation permits only the temporary authorisation of 
plant protection products containing an active substance which has not, or has not 
yet, been assessed at EU level, or the authorisation of products containing an 
approved active substance, for uses which have not, or have not yet, been 
authorised at national level. They base that conclusion on the following 
arguments: 
– Commission Working Document SANCO/10087/2013 of 1 February 2013, 
on the application of Article 53, recalls that the use of that provision should 
not undermine the purpose of ensuring a high level of protection for both 
human and animal health and that, for the purposes of granting authorisation 
for a product containing a non-approved active substance, Member States 
should take into account the need to ‘safeguard … the protection of human 
health and the environment’. 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-162/21 
 
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– Article 53 derogates from Article 28, which provides that a plant protection 
product is not to be placed on the market or used unless it has been 
authorised, but not from Article 29, which makes such authorisation subject 
to approval of the active substances, or from Article 4, which sets out the 
approval criteria for those substances.  
– Article 53 reproduces almost word for word Article 8(4) of Council 
Directive 91/414/EEC of 15 July 1991 concerning the placing of plant 
protection products on the market, 6 but differs from it in two essential 
respects:  
– Article 8(4) of the directive introduced a derogation from Article 4 
thereof, which made authorisation to place plant protection products on 
the market conditional, inter alia, upon the approval of their active 
substances. Article 53 of the regulation contains no derogation from 
Article 29 thereof, which imposes the same condition.  
– Article 8(4) of the directive expressly provided for the possibility of 
authorising the placing on the market of products not complying with 
Article 4 thereof. Article 53 does not provide for such a possibility for 
products not complying with the requirements of Article 29, which 
include approval of the active substances in accordance with Article 4. 
– The positions of the European Parliament, both before and after the adoption 
of the regulation, prove that the absence of an express derogation from 
Article 29 in Article 53 is the result of the EU legislature’s intention. 
Recital 32 of the regulation, which has no binding legal force and uses terms 
very different from those of Article 53, does not support the conclusion that 
this is a simple oversight and that Article 53 contains an implied derogation 
from Article 29. 
– The scope of any hypothetical implied derogation from Article 29 would be 
very uncertain and could not, in particular, allow the use of a product which 
clearly does not comply with that provision and, consequently, with the 
conditions of approval of the substances laid down in Article 4(3).  
– In any event, Article 53 does not allow a derogation from measures adopted 
on the basis of Articles 21(3) and 49(2) of the regulation, such as 
Implementing Regulations 2018/784 and 2018/785, which prohibit the uses 
covered by the contested decisions. 
– Those prohibitions are based on a rigorous scientific assessment and were 
dictated by the precautionary principle. A Member State wishing to derogate 
from such a prohibition would, in any event, have to rely on new scientific 
assessments or data which could call into question the EFSA’s conclusions 
 
6  OJ 1991 L 230, p. 1. 
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as to the hazardousness of the substance or use on which the prohibition is 
based. 
35 The applicants take the view that any other interpretation of Article 53 would be 
contrary to the principle of integrated pest management set out in Article 14 of 
Directive 2009/128, which makes the use of pesticides subject to compliance with 
a principle of subsidiarity. 
36 More specifically, an interpretation which exempts Member States from 
complying with the requirements of Article 4 of the regulation would be contrary 
to Articles 35 and 37 of the Charter. An interpretation allowing each Member 
State unilaterally to call into question prohibitions decided at EU level would in 
turn jeopardise the effectiveness of Regulation No 1107/2009, recital 9 of which 
states that it should ‘lay down harmonised rules for the approval of active 
substances and the placing on the market of plant protection products’. 
37 In the alternative, the applicants request that the Conseil d’État refer a question to 
the Court for a preliminary ruling, to determine whether Article 53 allows a 
Member State to authorise uses of plant protection products expressly prohibited 
by EU law because of the risks which they pose to the environment or health. 
Position of the Belgian State 
38 The Belgian State takes the view that a distinction should be drawn between the 
provisions of Article 4 et seq. of Regulation No 1107/2009, relating to the 
approval of active substances, and the provisions of Articles 28 and 29 et seq., 
relating to authorisation for the placing on the market and use of plant protection 
products. 
39 It submits that Article 53 introduces an express derogation from the general 
principle set out in Article 28, but also an implied derogation from the ordinary 
authorisation procedure for plant protection products provided for by Article 29. 
40 Recital 32 of the regulation, which states that ‘in exceptional cases, Member 
States should be permitted to authorise plant protection products not complying 
with the conditions provided for in this Regulation, where it is necessary to do so 
because of a danger or threat to plant production or ecosystems which cannot be 
contained by any other reasonable means …’, demonstrates that the absence of an 
express derogation from Article 29 is the result of a simple oversight and not the 
intention of the legislature. 
41 That implied derogation from Article 29 may be used for any plant protection 
product containing active substances which have not been approved on the basis 
of the regulation, whether because the approval procedure is still pending, because 
certain uses of that product are not authorised by the Annex to Implementing 
Regulation No 540/2011, or because any approval granted at a given time was 
withdrawn. 
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42 That interpretation follows from the Commission’s consistent practice, is in 
accordance with the wording of Article 53, and does not conflict with the Charter, 
with the principle of integrated pest management set out in Directive 2009/128, or 
with the effectiveness of Regulation No 1107/2009. 
43 The Belgian State also relies on the judgment of 17 October 2013, Sumitomo 
Chemical, C-210/12, EU:C:2013:665, from which it infers that the derogation in 
Article 53 does not require the Member States to carry out scientific risk 
evaluations prior to issuing such an authorisation, and maintains that the 
applications for derogation under Article 53 which have been submitted to it have 
been the subject of a very detailed scientific assessment and examination. 
44 In the alternative, it requests that the Conseil d’État refer a question to the Court 
for a preliminary ruling, to determine whether Article 53 allows a Member State 
to authorise the placing on the market of plant protection products, for limited and 
controlled use, in respect of uses which are non-approved, or even prohibited, 
under the Annex to Regulation No 540/2011, where such a measure appears 
necessary because of a danger which cannot be contained by any other reasonable 
means. 
Position of the interveners 
45 The CBB takes the view that Article 53 of Regulation No 1107/2009 derogates 
not only from Article 28 but also from the ordinary authorisation procedure for 
plant protection products provided for by Article 29 and, consequently, from the 
conditions of approval for active substances laid down by Article 4(3). It therefore 
permits the authorisation of plant protection product uses that are expressly 
prohibited by the European Union, and not only uses of products containing an 
active substance which has not, or has not yet, been assessed at EU level. The 
CBB bases that conclusion on the following arguments: 
– Regulation No 1107/2009 is the only measure of EU law which 
distinguishes between the concepts of ‘approved active substance’ and ‘non-
approved active substance’.  
– Non-approved active substances are those which do not satisfy the 
conditions for authorisation under Article 4, and include both substances 
which have not yet been assessed and substances which have been assessed 
and prohibited.  
– The hazardousness of substances which have been assessed is known, 
whereas the hazardousness of substances which have not, or have not yet, 
been assessed is essentially unknown.  
– The authorities to whom an application for a derogation under Article 53 is 
made may make an informed evaluation of a substance which has been 
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assessed and prohibited, but cannot do the same in the case of a substance 
which has not, or has not yet, been assessed. 
46 The other interveners refer, in essence, to the arguments put forward by the 
Belgian State. 
Third part of the single plea 
Position of the applicants 
47 The applicants take them view that the contested authorisations were issued as a 
preventive measure, with a view to fulfilling an economic profitability imperative, 
and do not comply with the conditions for the application of Article 53 of 
Regulation No 1107/2009, relating to emergency, the existence of special 
circumstances and the absence of reasonable alternatives. 
48 As regards emergency, they argue as follows:  
– Emergency is referred to only in the title of Article 53. The Court has 
nevertheless always attached importance to the title of provisions in 
interpreting their meaning and scope. In the judgment of 17 October 2013, 
Sumitomo Chemical, C-210/12, EU:C:2013:665, it also referred to 
derogating authorisations as ‘emergency marketing authorisations’. 
– The contested decisions were taken on 19 October and 7 December 2018, 
when the crops concerned had not yet been sown. The targeted pests were 
therefore not yet present. 
– The applications for authorisation for Cruiser 600 FS recognise that it is not 
possible to know in advance where pest attacks might occur. 
The contested decisions are therefore not justified by any emergency. 
49 As regards special circumstances, the applicants argue as follows:  
– Pest attacks are closely linked to the crops concerned and may occur each 
year. Farmers are continually faced with a moderate presence of the pests 
targeted by the contested decisions.  
– The risk of proliferation of those pests is the logical and predictable 
consequence of unnecessary agricultural practices.  
– The fact that the occurrence of a pest is probable is not sufficient to establish 
the danger of significant damage to agricultural yields. The extent of the 
probable damage depends on how early a pest attack occurs and the number 
of pests observed, or at least anticipated. The figures produced in that regard 
by the interveners are not based on independent studies, are inconclusive and 
exaggerate the seriousness of the consequences of pest attacks. 
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The contested decisions are therefore not justified by any special circumstances. 
50 As regards the absence of reasonable alternatives, the applicants argue as follows: 
– No country in the same climatic zone as Belgium has granted a similar 
derogation from the contested decisions, though this has had no impact on 
yields in 2019.  
– The political advisor of the Vlaams Gewest (Flemish Region, Belgium) 
states that (chemical) alternatives are actually available in Belgium, even if 
farmers are not yet familiar with them. 
– The Institut royal belge pour l’amélioration de la betterave (Royal Belgian 
Institute for Beet Improvement) has drawn the attention of beet growers to 
the availability of alternative insecticides. Data available on its website show 
that 70 to 85% of them decided not to use neonicotinoid-treated seeds in 
2019 and that those alternatives have proven to be effective. 
– Alternatives include organic farming, which uses no synthetic pesticides, as 
well as a combination of crop rotation and other effective insecticides. 
– The implementation of Article 53 cannot, in any event, be justified by the 
mere lack of reasonable alternatives or the economically suboptimal nature 
of alternative techniques. Permitting States to continue to authorise a plant 
protection product prohibited at EU level on the sole ground that no 
alternative can match its performance would actually render the prohibition 
meaningless. 
– It is also clear from the wording of Article 53 that the absence of any other 
reasonable means of pest control is not in itself tantamount to proof of 
special and emergency circumstances. 
51 Finally, as regards the relative importance of economic imperatives, the applicants 
argue as follows: 
– The Belgian State confined itself to the irrelevant assertions contained in the 
requests for derogation under Article 53, whereas it could have demanded 
further explanations from the applicants or carried out its own independent 
scientific examination of the plausibility of the yield losses referred to.  
– Recital 8 of the regulation states that the purpose of that regulation ‘is to 
ensure a high level of protection of both human and animal health and the 
environment and at the same time to safeguard the competitiveness of 
Community agriculture. … The precautionary principle should be 
applied ….’. Article 1(4) of the regulation provides that ‘‘the provisions of 
[the] Regulation are underpinned by the precautionary principle …’. 
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– The Commission’s working document of 1 February 2013 states that 
applications for derogations under Article 53 ‘solely based on industry 
interests should be refused’. 
Even if economic imperatives are relevant, the EU legislature chose to give 
greater importance to the values of respect for health and the environment. The 
Belgian State adopted the opposite approach. 
52 In the alternative, the applicants request that the Conseil d’État refer a question to 
the Court for a preliminary ruling, to determine whether: 
– the expression ‘emergency situations’ covers situations in which a danger 
that is not certain to occur has not yet arisen. 
– the expression ‘special circumstances’ covers situations closely linked to 
specific agricultural practices and to which growers using those practices are 
primarily exposed, such as the risk of a proliferation of insect pests in crops 
with which those insects are naturally associated. 
– the expression ‘which cannot be contained by any other reasonable means’ 
covers an absence of means to ensure that a grower, in the short term, has 
the same productivity, costs and working time as those which are associated 
with use of the plant protection products for which authorisation is sought. 
Position of the Belgian State 
53 The Belgian State refers to the judgment of 17 October 2013, Sumitomo Chemical, 
C-210/12, EU:C:2013:665, and takes the view that the application of Article 53 of 
Regulation No 1107/2009 is not conditional upon an emergency situation, the 
existence of special circumstances or the absence of reasonable alternatives. 
54 The derogation is intended to respond to a danger which cannot be contained by 
any other reasonable means. It is therefore not relevant to examine whether or not 
the identified danger is foreseeable, or whether the occurrence of pest attacks is 
closely linked to the crops in question. 
55 The Belgian State argues that the Approval Committee systematically considered 
alternatives to the use of the substances in question and that it relied on expert 
opinions in taking the view that there was no reasonable alternative for controlling 
the pests identified in the contested decisions. 
56 In the alternative, the Belgian State requests that the Conseil d’État refer a 
question to the Court for a preliminary ruling, to determine, first, whether 
Article 53 covers only situations in which the danger is unforeseeable at the time 
of the adoption of a derogating measure and, secondly, whether the expression 
‘which cannot be contained by any other reasonable means’ makes it possible to 
safeguard the competitiveness of Community agriculture within the meaning of 
recital 8 of the regulation. 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-162/21 
 
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Position of the interveners 
57 The CBB submits that Article 53 of Regulation No 1107/2009 does not require 
proof of an emergency or exceptional circumstances. Those concepts are 
equivalent to establishing the existence of ‘a danger or threat to plant production 
or ecosystems which cannot be contained by any other reasonable means’. In the 
present case, the existence of special circumstances, justifying a derogation 
measure because of a danger which cannot be contained by any other reasonable 
means, has been established. 
58 The other interveners take the view that the applicants rely on organic farming to 
establish the existence of alternatives, but argue that that method does not provide 
an effective remedy in the present case. 
IV. Assessment of the Conseil d’État:  
59 The parties differ in their interpretations of the scope of Article 53 of Regulation 
No 1107/2009 and the requirements for its implementation. 
60 The application of Article 53 is not so obvious as to leave no room for reasonable 
doubt. 
61 In particular, the applicants request that the Conseil d’État refer to the Court for a 
preliminary ruling questions which appear to be relevant and which relate to the 
interpretation of several concepts contained in that provision. 
62 The Court has not yet interpreted those concepts. It should therefore be requested 
to do so by way of a reference for a preliminary ruling. 
V. The questions referred: 
1. Is Article 53 of 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 to be interpreted as allowing a Member State to grant, in certain 
circumstances, an authorisation for the treatment, sale or sowing of seeds treated 
with plant protection products? 
2. If the answer to the first question is in the affirmative, can the 
aforementioned Article 53 be applied, in certain circumstances, to plant protection 
products containing active substances the marketing or use of which is restricted 
or prohibited in the territory of the European Union? 
3. Do the ‘special circumstances’ required by Article 53 of the aforementioned 
regulation cover situations in which the occurrence of a danger is not certain but 
only plausible? 
PESTICIDE ACTION NETWORK EUROPE AND OTHERS 
 
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4. Do the ‘special circumstances’ required by Article 53 of the aforementioned 
regulation cover situations in which the occurrence of a danger is foreseeable, 
common and even cyclical?  
5. Is the expression ‘which cannot be contained by any other reasonable 
means’, as used in Article 53 of the regulation, to be interpreted as giving equal 
importance, in the light of the wording of recital 8 of the regulation, on the one 
hand, to ensuring a high level of protection of both human and animal health and 
the environment and, on the other hand, to safeguarding the competitiveness of 
Community agriculture?