Opinion of the Advocate General — ECLI:EU:C:2019:549
Date: 2019-06-27
Language of the case: Dutch
Subject matter: Agriculture and Fisheries;Approximation of laws;Public health
Procedure: Reference for a preliminary ruling
Origin: Netherlands

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:  
9 July 2018 
Referring court:  
College van Beroep voor het Bedrijfsleven (Netherlands) 
Date of the decision to refer:  
3 July 2018 
Appellants:  
Vaselife International BV 
Chrysal International BV 
Respondent:  
College voor de toelating van gewasbeschermingsmiddelen en 
biociden 
  
Subject matter of the action in the main proceedings 
The dispute in the main proceedings concerns the extension of the period of 
validity of a parallel trade permit previously granted to Vaselife International BV 
(‘Vaselife’) for the plant protection product Vaselife Universal Bulb PHT 
(‘Vaselife UB’) in a situation where the College voor de toelating van 
gewasbeschermingsmiddelen en biociden (Netherlands Board for the 
Authorisation of Plant Protection Products and Biocides; ‘the Ctgb’) had a short 
time previously taken a decision to re-register the reference product.  
Subject matter and legal basis of the request for a preliminary ruling 
The subject matter of this request under Article 267 TFEU relates to the question 
whether the Ctgb, after the re-registration of a plant protection product, may 
extend the validity of a parallel trade permit based on it, and if so, whether the 
Ctgb should effect that extension by operation of law or whether, following re-
EN 
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registration, it must first, whether or not of its own motion, take a decision on the 
extension of the parallel trade permit. Particularly at issue in this regard is the 
question whether the Ctgb has the power, prior to a possible extension, to assess 
whether the criteria for parallel trade laid down in Article 52(3) of Regulation 
No 1107/2009 are still satisfied.  
Questions referred 
1. Is the competent authority, the College voor de toelating van 
gewasbeschermingsmiddelen en biociden (Netherlands Board for the 
Authorisation of Plant Protection Products and Biocides; ‘the Ctgb’), authorised, 
after having taken a decision to re-register the reference product, whether or not of 
its own motion, to change the period of validity of a parallel trade permit as 
referred to in Article 52 of Regulation (EC) No 1107/2009, where that permit was 
granted before the re-registration decision, in accordance with the - later - date of 
the period of validity applying to the decision to re-register the reference product?  
2. If Question 1 is answered in the affirmative, is the change to the period of 
validity of a parallel trade permit an automatic consequence of a decision to re-
register the reference product resulting from Regulation (EC) No 1107/2009 
itself? Is the entry of the new date of the period of validity of the parallel permit 
into the database of the competent authority thus a purely administrative act, or 
does it require a decision taken by that authority of its own motion or in response 
to a request?  
3. If the answer to Question 2 is that a decision must be taken, does Article 52 
of Regulation (EC) No 1107/2009, and in particular, the third paragraph of that 
article, apply to that decision?    
4. If Question 3 is answered in the negative, which provision(s) is/are then 
applicable? 
5. Can a plant protection product already be considered not to be identical 
within the meaning of Article 52 of Regulation (EC) No 1107/2009 if the 
reference product does not (any longer) originate from the same undertaking? The 
Court of Justice is requested, in answering that question, also to consider whether 
the notion of an associated undertaking or of an undertaking operating under 
licence can also include an undertaking which produces the product according to 
the same recipe, with the consent of the right-holder. Is it relevant here whether 
the production process according to which the reference product and the parallel 
product which is to be introduced are manufactured is carried out by the same 
undertaking as far as the active substances are concerned?  
6. Is the mere changing of the location for the production of the reference 
product relevant to the assessment of whether the product is identical? 
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7. If Questions 5 and/or 6 are/is answered in the affirmative, can the conclusion 
to be drawn therefrom (‘not identical) be undermined by the fact that the 
competent authority has already established that, as regards its composition, the 
product has not undergone any change or has undergone only a slight change?  
8. On whom and to what extent does the burden of proof lie to show that 
Article 52(3) of Regulation (EC) No 1107/2009 has been satisfied if the holders of 
the authorisation for the parallel product and for the reference product have a 
difference of opinion in that regard?  
The provisions of EU law cited 
Articles 28, 29, 43, 44, 52 and 56 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 (OJ 2009 L 309, p. 1).  
The provisions of national law cited 
Article 1:3(1) of the Algemene wet bestuursrecht (General Administrative Law); 
‘the Awb’). That article reads: ‘“Decision” shall mean: a written decision of an 
administrative authority, constituting a legal act under public law.’ 
Brief summary of the facts and procedure in the main proceedings 
1 The Ctgb is the competent authority for the Netherlands within the meaning of 
Article 75 of Regulation No 1107/2009. By decision of 12 June 2015, it granted 
Vaselife a parallel trade permit for the plant protection product Vaselife UB 
(authorisation number 14878N). The Ctgb accepted Vaselife’s application because 
the product did not differ materially from the product VBC-476, 12865N, which 
was authorised in the Netherlands and manufactured by Valent Biosciences 
Corporation BV. The authorisation of that reference product was initially valid 
until 31 December 2016. However, by decision of 23 December 2015, the Ctgb 
decided to re-register the product, as a result of which the holder of the 
authorisation for that product was changed from Valent Biosciences to Sumitomo 
Chemical Agro Europe SAS and the expiry date was given as 1 December 2025. 
Subsequently, by decision of 19 February 2016, the authorisation, at Sumitomo’s 
request, was transferred to Chrysal International BV (‘Chrysal’). Also by decision 
of 19 February 2016, the Ctgb accepted Sumitomo’s application for a minor 
change in the composition of the authorised plant protection product VBC-476. 
The authorisation number remained 12865N and the expiry date remained 
1 December 2025. Furthermore, Chrysal requested that the name of the product 
concerned be changed to Chrysal BVB. That request was granted by decision of 
3 June 2016.  
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2 By decision of 1 March 2016 (primary decision), the Ctgb decided to extend the 
parallel permit for Vaselife UB until 1 December 2025. That decision states that 
the product is identical, within the meaning of Article 52(3) of Regulation 
No 1107/2009, to the product VBC-476, 12865N, the authorisation of which was 
extended in the Netherlands, so that the parallel permit can also be extended.  
3 On 1 April 2016, Chrysal lodged an objection against the primary decision. The 
Adviescommissie voor de bezwaarschriften (Advisory Committee on objections) 
of the Ctgb was of the opinion that the concept of an application for an extension 
was totally unknown in Article 52 of Regulation No 1107/2009, let alone that such 
an application could be assessed under the third paragraph of that article. It 
follows from Article 52(6) of the Regulation that the expiry date of the parallel 
trade permit automatically follows the authorisation period of the reference 
product. In the present case, therefore, that expiry date was changed to 
1 December 2025 by operation of law. According to the Adviescommissie, that 
new date had only to be entered in the authorisations database. There was 
therefore no question of a legal act and therefore also not of a decision within the 
meaning of Article 1:3(1) Awb. Therefore, Chrysal’s objection had to be declared 
inadmissible.  
4 In dealing with Chrysal’s objection, the Ctgb did not share the opinion of the 
Adviescommissie. The Ctgb inferred from the European Commission’s ‘Guidance 
document concerning the parallel trade of plant protection products’, which is 
available only in English, [...]  (‘Guidance document’), that the expiry date of a 
parallel trade permit must be changed as soon as the expiry date of the reference 
product is changed. That this does not happen by operation of law, as the 
Adviescommissie submitted, but by the adoption of a decision, was borne out, 
according to the Ctgb, by point 8 of the Guidance document (see p. 15): ‘Renewal 
of parallel trade permits. Upon the expiry date of a parallel trade permit a new 
application needs to be submitted according to the provisions of Article 52 of 
Regulation (EC) No 1107/2009. The assessment of these applications against the 
criteria of Article 52 will be conducted considering them as new applications.’ 
5 According to the Ctgb, it follows therefore that the objection lodged by Chrysal 
against that decision was admissible. Moreover, by decision of 26 April 2017 (‘the 
contested decision’), the Ctgb declared that objection to be partially well founded. 
While it is true that, despite the minor change adopted by the decision of 
26 February 2016, the composition of the plant protection product in question 
was, within the meaning of Article 52(3)(b) and (c) of Regulation No 1107/2009, 
still identical to that of the product for which the original parallel trade permit had 
been granted, there was no longer any question of a common origin as required by 
Article 52(3)(a) of that regulation. After all, the authorisation had been acquired 
by Chrysal, which was not associated with Valent and did not operate under 
licence from Valent. Furthermore, the production location of the product had been 
changed. Vaselife’s application for an extension of the parallel trade permit was 
therefore rejected. However, Vaselife was allowed to trade batches of the product 
which had already been introduced and notified. By decision of 20 July 2017, the 
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respondent further extended the grace period granted by allowing any other 
batches which had not been included in the earlier decision to be traded.  
6 Vaselife lodged an appeal against the contested decision before the referring court. 
Chrysal has been admitted as a third party in these proceedings. At the same time, 
Chrysal lodged an appeal against the decision of 20 July 2017 to grant a grace 
period, an action in which Vaselife is a third party. Both undertakings are 
therefore applicants in different cases, while the referring court is, however, 
dealing with these as joined cases. The request for a preliminary ruling relates in 
the first instance to the appeal brought by Vaselife but, because of the close 
connection, is also relevant to the appeal brought by Chrysal.   
Main submissions of the parties to the main proceedings 
7 Vaselife submits that Article 52 of Regulation No 1107/2009 applies solely to a 
new application for a parallel trade permit. As soon as the first three paragraphs of 
Article 52 have been complied with and a parallel trade permit has been granted, 
the term of the permit granted automatically follows the term of the authorisation 
for the reference product. Primarily, Vaselife takes the position that that automatic 
extension does not require any decision on the part of the administrative body 
concerned and that that modification is therefore not a decision within the 
meaning of Article 1:3(1) Awb. As the Adviescommissie has stated, the new date 
need only be entered in the authorisations database. This follows from Article 
52(6) of Regulation No 1107/2009 and from point 6.2 of the Guidance document. 
This, it argues, is also how the Regulation is interpreted in the United Kingdom. 
That is clear from the document, available on the internet, of the Health and 
Safety Executive, entitled: ‘Parallel Trade Permit Procedure – Guidance for 
introduction, use and placing on the UK market of parallel trade” [...] 
(http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-
registration/applicant-guide/parallel-trade-permit-procedure.htm). 
8 Vaselife submits, in the alternative, that Article 52(3) of Regulation No 1107/2009 
is not applicable here. By examining whether the conditions laid down in that 
article had been satisfied, the Ctgb acted contrary to that regulation. The Ctgb 
wrongly relied on point 8 of the Guidance document (see above under 4). That 
point applies only once the term of the authorisation of the reference product has 
expired. The Guidance document merely states that, after expiry of a parallel trade 
permit, a new application must be submitted which must be assessed against 
Article 52(3). The present case relates to an extension during the currency of a 
parallel trade permit granted and not to a new application after the expiry of a 
previous (expired) parallel trade permit. During the currency of a parallel trade 
permit, the Ctgb may, at most, examine whether there are reasons for withdrawing 
that permit. Withdrawal is possible only on the basis of the (analogous application 
of) Articles 29, 44 and Article 52(8) of Regulation No 1107/2009 or if the 
authorisation of the reference product has been withdrawn. The latter follows from 
the connection between the parallel trade permit and the provisions relating to the 
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authorisation of the reference product laid down in Article 52(5) and (6) of 
Regulation No 1107/2009.  
9 In the event that Article 52(3) of Regulation No 1107/2009 does apply, Vaselife 
argues in the further alternative that the primary decision which granted the 
parallel trade permit is correct. Vaselife submits that the contested decision 
incorrectly found that the product Vaselife UB and the reference product no 
longer had a common origin within the meaning of subparagraph (a) of that 
provision. The Ctgb, it argues, should not have based that finding on the change in 
the production location and on the fact that Valent and Chrysal are not associated 
companies.  
10 Vaselife further substantiates that argument by referring to the case-law of the 
Court of Justice concerning the legislation and regulations that applied prior to the 
entry into force of Regulation No 1107/2009 (judgments of 11 March 1999, 
British Agrochemicals Association, C-100/96, EU:C:1999:129, and of 
21 February 2008, Commission v France, C-201/06, EU:C:2008:104), on which 
the wording of Article 52 of that regulation is based. It follows from that case-law 
that the requirement of a common origin was laid down to make it easier to 
distinguish a parallel trade permit from other situations in which the importer of a 
product authorised in another Member State wishes to benefit from a permit 
allowing a product to be placed on the market, granted in the Member State of 
introduction. Furthermore, it follows from that case-law that, if a parallel trade 
permit already exists, that is an important indication that the imported product and 
the reference product are identical. That should have been the point of departure. 
A decision to the contrary may be made only on the basis of sufficient other 
information.  
11 Vaselife submits that, furthermore, it is also clear from point 4.1 of the Guidance 
document that in the present case there is an undertaking operating ‘under licence’ 
within the meaning of Article 52(3)(a) [of Regulation No 1107/2009]. According 
to that point 4.1, there need not necessarily be a licence in the strict civil-law 
sense by means of a formal agreement. The production of a product by the one, 
according to a recipe from the other, is sufficient. It can be deduced from the 
available information that Chrysal produces, or assembles, the product developed 
by Valent for the Netherlands market from active ingredients that it has bought 
from Valent. In that case there is still a ‘common origin’ as contemplated in 
Article 52(3) of Regulation No 1107/2009. This, too, indicates that the Ctgb 
should have taken the existing situation as its point of departure, which showed 
that there was a common origin and that it could have concluded that that was no 
longer the case only if Chrysal had provided conclusive evidence to the contrary. 
Since Chrysal has not done so, a ‘common origin’ must be assumed.  
12 In the main proceedings, the Ctgb provides further substantiation of its views as 
expressed in the primary decision. It states again that the extension of the expiry 
date of a parallel permit is a legal consequence of a legal act, with the result that 
the extension in the present case took place by means of a decision. Moreover, 
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that required an application which, after the lodging of an objection, could still be 
rejected on the ground that, at the time of that decision, there was no longer an 
identical plant protection product within the meaning of Article 52 of Regulation 
No 1107/2009. That test did not take place during the currency of the parallel 
permit, but was carried out in anticipation of its expiry. In the alternative, the Ctgb 
refers to Article 44(3)(c) of Regulation No 1107/2009, under which it must 
withdraw the authorisation if the conditions included therein are no longer met. 
Under Article 52(7) of that regulation, that article applies to parallel permits 
correspondingly. 
13 According to the Ctgb, the position taken by Vaselife means that, once a parallel 
permit has been granted, the Ctgb may never again assess whether the conditions 
for the authorisation of a parallel product have been met. If that view is accepted, 
there is a risk that an imported product may, without being noticed, develop 
further in a manner which diverges from the reference product, with the result that 
plant protection products that pose risks to humans, animals and the environment 
may possibly be used in the Netherlands. It is therefore desirable that the Ctgb 
should be able periodically to assess whether the product to be imported is still 
identical to the reference product. In the present case, the change of producer, 
authorisation holder and production location were sufficient to establish that that 
requirement was no longer being met.  
14 Chrysal observes, as a third party, that Vaselife’s view is that, once a parallel 
permit has been granted in accordance with Article 52 of Regulation 
No 1107/2009, a parallel permit must be granted each time a subsequent 
application is made, unless the holder of the authorisation for the reference 
product proves that the criteria laid down in that article are no longer being met. 
That approach considerably increases the burden on holders of authorisations for 
reference products. Moreover, Article 52 of Regulation No 1107/2009 does not 
provide any basis for this and that approach does not accord with the objective and 
scope of the parallel trade regime or the fact that what is at issue here is a decision 
on demand.  
Brief summary of the reasons for the referral 
15 The parties to the main proceedings rely in part on the same articles of Regulation 
No 1107/2009, but interpret them differently. They have also referred to case-law 
of the Court of Justice. In addition to the judgments mentioned in the respective 
positions of the parties, the referring court also refers to the judgment of 1 April 
2004, Kohlpharma, C-112/02, EU:C:2004:208. However, that case-law relates to 
laws and regulations that applied prior to the entry into force of Regulation 
No 1107/2009. Therefore, in view of the lack of clarity in the interpretation of 
Article 52 of that latter regulation, the referring court is obliged to refer the 
questions as formulated above to the Court of Justice for a preliminary ruling.