Court of Justice of the European Communities (including Court of First Instance Decisions)

Provisional text

OPINION OF ADVOCATE GENERAL

HOGAN

delivered on 27 June 2019(1)

Case C‑445/18

Vaselife International BV,

Chrysal International BV

v

College voor de toelating van gewasbeschermingsmiddelen en biociden

(Request for a preliminary ruling from the College van Beroep voor het Bedrijfsleven (Administrative Court of Appeal for Trade and Industry, Netherlands))

(Request for a preliminary ruling — Placing on the market of plant protection products — Parallel trade — Modification of the period of validity of the parallel permit — Identity of the plant protection product and the reference product — Conditions)

I.      Introduction

1.        The present request for a preliminary ruling concerns the interpretation of Article 52 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. (2)

2.        The request was made in proceedings between Vaselife International BV (‘Vaselife’), Chrysal International BV (‘Chrysal’) and the College voor de toelating van gewasbeschermingsmiddelen en biociden (Netherlands Board for the Authorisation of Plant Protection Products and Biocides, ‘the Ctgb’) concerning, in essence, the Ctgb’s refusal to renew a permit of parallel trade, previously granted to Vaselife, after having authorised the re-registration of the reference product in favour of Chrysal.

II.    Legal context

3.        Recitals 8, 9, 24, 29 and 33 of Regulation No 1107/2009 state:

‘(8) The purpose of this 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. Particular attention should be paid to the protection of vulnerable groups of the population, including pregnant women, infants and children. The precautionary principle should be applied and this Regulation should ensure that industry demonstrates that substances or products produced or placed on the market do not have any harmful effect on human or animal health or any unacceptable effects on the environment.

(9) In order to remove as far as possible obstacles to trade in plant protection products existing due to the different levels of protection in the Member States, this Regulation should also lay down harmonised rules for the approval of active substances and the placing on the market of plant protection products, including the rules on the mutual recognition of authorisations and on parallel trade. The purpose of this Regulation is thus to increase the free movement of such products and availability of these products in the Member States.

…

(24) The provisions governing authorisation must ensure a high standard of protection. In particular, when granting authorisations of plant protection products, the objective of protecting human and animal health and the environment should take priority over the objective of improving plant production. …

…

(29) The principle of mutual recognition is one of the means of ensuring the free movement of goods within the Community. To avoid any duplication of work, to reduce the administrative burden for industry and for Member States and to provide for more harmonised availability of plant protection products, authorisations granted by one Member State should be accepted by other Member States where agricultural, plant health and environmental (including climatic) conditions are comparable. Therefore, the Community should be divided into zones with such comparable conditions in order to facilitate such mutual recognition. However, environmental or agricultural circumstances specific to the territory of one or more Member States might require that, on application, Member States recognise or amend an authorisation issued by another Member State, or refuse to authorise the plant protection product in their territory, where justified as a result of specific environmental or agricultural circumstances or where the high level of protection of both human and animal health and the environment required by this Regulation cannot be achieved. …

…

(33) Community seeds legislation provides for free movement of seeds within the Community but does not contain a specific provision concerning seeds treated with plant protection products. Such a provision should therefore be included in this Regulation. If treated seeds constitute a serious risk to human or animal health or to the environment, Member States should have the possibility of taking protective measures.’

4.        Article 1 of Regulation No 1107/2009 defines its subject matter and purpose. According to Article 1(3):

‘The purpose of this Regulation 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 through the harmonisation of the rules on the placing on the market of plant protection products, while improving agricultural production.’

5.        Article 28 of Regulation No 1107/2009 is entitled ‘Authorisation for placing on the market and use’. It provides:

‘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.

2. By way of derogation from paragraph 1, no authorisation shall be required in the following cases:

…

(e)      placing on the market and use of plant protection products for which a parallel trade permit has been granted in accordance with Article 52.’

6.        Article 43 of Regulation No 1107/2009, entitled ‘Renewal of authorisation’, provides:

‘1. An authorisation shall be renewed upon application by the authorisation holder, provided that the requirements referred to in Article 29 are still met.

…

5. Member States shall decide on the renewal of the authorisation of a plant protection product at the latest 12 months after the renewal of the approval of the active substance, safener or synergist contained therein.

6. Where, for reasons beyond the control of the holder of the authorisation, no decision is taken on the renewal of the authorisation before its expiry, the Member State in question shall extend the authorisation for the period necessary to complete the examination and adopt a decision on the renewal.’

7.        Article 44 of Regulation No 1107/2009, entitled ‘Withdrawal or amendment of an authorisation’, provides:

‘1. Member States may review an authorisation at any time where there are indications that a requirement referred to in Article 29 is no longer satisfied.

…

2. Where a Member State intends to withdraw or amend an authorisation, it shall inform the authorisation holder and give him the possibility to submit comments or further information.

3. The Member State shall withdraw or amend the authorisation, as appropriate, where:

(a)      the requirements referred to in Article 29 are not or are no longer satisfied;

…’

8.        Article 45(1) of Regulation No 1107/2009 states that ‘an authorisation may be withdrawn or amended at the request of the holder of the authorisation, who shall state the reasons for his request’.

9.        Article 52 of Regulation No 1107/2009, entitled ‘Parallel trade’, provides:

‘1. A plant protection product that is authorised in one Member State (Member State of origin) may, subject to granting a parallel trade permit, be introduced, placed on the market or used in another Member State (Member State of introduction), if this Member State determines that the plant protection product is identical in composition to a plant protection product already authorised in its territory (reference product). The application shall be submitted to the competent authority of the Member State of introduction.

2. From receiving a complete application, a parallel trade permit shall be granted in a simplified procedure within 45 working days if the plant protection product to be introduced is identical in terms of paragraph 3. Member States shall on request provide each other with the information necessary to assess whether the products are identical within 10 working days of receiving the request. The procedure for granting a parallel trade permit is interrupted from the day the request for information is sent to the competent authority of the Member State of origin until the complete information required is delivered to the competent authority of the Member State of introduction.

3. Plant protection products shall be considered as identical to the reference products if:

(a)      they have been manufactured by the same company or by an associated undertaking or under licence in accordance with the same manufacturing process;

(b)      they are identical in specification and content to the active substances, safeners and synergists, and in the type of formulation; and

(c)      they are either the same or equivalent in the co-formulants present and the packaging size, material or form, in terms of the potential adverse impact on the safety of the product with regard to human or animal health or the environment.

…

6. The parallel trade permit shall be valid for the duration of authorisation of the reference product. If the authorisation holder of the reference product applies for a withdrawal of authorisation in accordance with Article 45(1) and the requirements of Article 29 are still fulfilled, the validity of the parallel trade permit shall expire by the date on which the authorisation of the reference product would normally have expired.

7. Without prejudice to specific provisions of this Article, Articles 44, 45, 46, and 55 and Article 56(4) and Chapters VI to X shall apply to parallel traded plant protection products correspondingly.

8. Without prejudice to Article 44, a parallel trade permit may be withdrawn if the authorisation of the introduced plant protection product is withdrawn in the Member State of origin because of safety or efficacy reasons.

9. Where the product is not identical, in terms of paragraph 3, to the reference product, the Member State of introduction may only grant the authorisation required for placing on the market and use in accordance with Article 29.

…’

III. Facts of the main proceedings

10.      Vaselife holds a parallel trade permit for the plant protection product Vaselife Universal Bulb PHT (‘Vaselife UB’). This product is imported from Italy where it is registered and authorised under the name Promalin. This product is identical to the product VBC‑476, which is authorised in the Netherlands and manufactured by Valent Biosciences, a division of Sumitomo. These products are growth regulators. The first is used for apples and pears, the second for cut flowers. The Ctgb granted the permit in question for a period expiring on 31 December 2016.

11.      Following Sumitomo’s application for re-registration of the authorisation of plant protection product VBC‑476, the Ctgb granted authorisation for this product by decision of 23 December 2015. This decision changes the identity of the holder of the authorisation for this product from Valent Biosciences to Sumitomo itself, and mentions 1 December 2025 as the expiry date.

12.      By decision of 19 February 2016, the Ctgb, at Sumitomo’s request, decided to modify the composition of the authorised plant protection product VBC-476. This was classified as a minor change. The authorisation nonetheless kept the same number and the expiry date is 1 December 2025. By a further Ctgb decision of the same day, the authorisation of the product VBC-476 was also transferred to Chrysal. This product was later renamed Chrysal BVB as authorised by a Ctgb decision of 3 June 2016.

13.      By decision of 1 March 2016, the Ctgb decided to renew the parallel trade permit issued on 12 June 2015 for the plant protection product Vaselife UB until 1 December 2025. To this end, the Ctgb relied on Article 52 of Regulation No 1107/2009, considering that the product Vaselife UB was manufactured by Valent Biosciences and therefore came from the same company as the reference product.

14.      Chrysal lodged an objection against that decision of 1 March 2016. The Ctgb, by decision of 26 April 2017, declared this complaint admissible and in part well founded. It withdrew its decision of 1 March 2016 and rejected Vaselife’s request to renew the decision of 12 June 2015 on the basis that Chrysal was not an associated undertaking of Valent Biosciences or an undertaking operating under licence granted by Valent Biosciences and that the location of production had changed. The Ctgb accordingly decided that Vaselife no longer fulfilled the conditions required by Article 52 of Regulation No 1107/2009. A grace period was, however, granted to Vaselife by the Ctgb.

15.      An appeal was then brought by Vaselife against the Ctgb’s decision of 26 April 2017 before the referring court. For its part, Chrysal also lodged an appeal against the Ctgb’s decision of 20 July 2017 extending the grace period granted to Vaselife by the decision of 26 April 2017. Both undertakings are therefore applicants and, at the same time, third parties in the proceedings lodged by the other before the referring court, which is dealing with these as joined cases.

16.      The dispute in the main proceedings accordingly raises questions as to the period of validity of a parallel trade permit for a plant protection product where the reference product in the country of destination on which the parallel trade permit was based has been ‘re-registered’ and the related procedure. It also concerns the assessment of the identity requirements for the product concerned and the reference product for the purposes of Article 52(3) of Regulation No 1107/2009, and, finally, the burden of proof in the event of a dispute about the identity of the product and the reference product.

IV.    The request for a preliminary ruling and the procedure before the Court

17.      In those circumstances, by decision of 3 July 2018, received at the Court on 9 July 2018, the College van Beroep voor het Bedrijfsleven (Administrative Court of Appeal for Trade and Industry, Netherlands) decided to stay the proceedings and to refer the following questions to the Court for a preliminary ruling:

‘(1)      Is the competent authority, [“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 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 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 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 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?

(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 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?’

18.      Written observations were submitted by Vaselife, Chrysal, the Netherlands Government and by the European Commission. In addition, Vaselife, the Netherlands Government and the European Commission presented oral arguments at the hearing on 13 May 2019.

V.      Analysis

A.      The first four questions

19.      The first four questions concern the consequences of the decision taken by the competent authority to re-register a reference product on the validity of a parallel trade permit.

20.      With those questions, the referring court asks:

–        if the competent authority may, of its own motion or following a request, adjust the period of validity of a parallel trade permit to the later date of expiry of the re-registered reference product (first question);

–        if, this is so, such adaptation automatically follows from the decision to renew the authorisation of the reference product or if a separate decision is to be adopted (second question);

–        if, in the event that a separate decision is required, the competent authority must carry out a review with regard to the conditions laid down in Article 52(3) of Regulation No 1107/2009 (third question) or with regard to any other provision (fourth question).

21.      As those questions are all facets of the same issue, I propose to examine them together.

1.      Preliminary remarks on the necessity to give an answer in the light of Regulation No 1107/2009

22.      The renewal of the authorisation of a plant protection product is governed by Article 43 of Regulation No 1107/2009. First, Article 43(1) of Regulation No 1107/2009 provides that ‘an authorisation [of a plant protection product] shall be renewed upon application by the authorisation holder, provided that the requirements referred to in Article 29 are still met’. Article 43(5) further specifies that ‘Member States shall decide on the renewal of the authorisation of a plant protection product at the latest 12 months after the renewal of the approval of the active substance, safener or synergist contained therein’. Article 43(6) finally adds that ‘where, for reasons beyond the control of the holder of the authorisation, no decision is taken on the renewal of the authorisation before its expiry, the Member State in question shall extend the authorisation for the period necessary to complete the examination and adopt a decision on the renewal’.

23.      It is clear, therefore, from those provisions that a decision must be taken by the competent authority of the Member States to renew the authorisation of a plant protection product and that the plant protection product must satisfy the conditions laid down by Article 29 of Regulation No 1107/2009.

24.      On the contrary, that regulation does not contain any provision dealing with the issue of the renewal of a parallel trade permit. Article 52(6) of Regulation No 1107/2009 merely provides that ‘the parallel trade permit shall be valid for the duration of authorisation of the reference product. If the authorisation holder of the reference product applies for a withdrawal of authorisation in accordance with Article 45(1) and the requirements of Article 29 are still fulfilled, the validity of the parallel trade permit shall expire by the date on which the authorisation of the reference product would normally have expired’.

25.       However, as the Court pointed out in relation to the previous legislation concerning the placing of plant protection products on the market (3) — which, as it happens, did not then set out the conditions for the authorisation of a plant protection product covered by a marketing authorisation granted in accordance with its provisions and imported in parallel to a plant protection product already covered by a marketing authorisation in the Member State of importation — such a situation is likely to have an impact on the free movement of the goods concerned. (4)

26.      In those circumstances, it seems to me that the question of the impact of the renewal of the authorisation of the reference product on a parallel trade permit must be resolved in a uniform manner within the European Union in the light of Regulation No 1107/2009, having regard not only to its wording, but also its context and the objectives of that legislation. (5)

2.       Need to adopt a new decision and control the conditions laid down in Article 52(3) of Regulation No 1107/2009

27.      Article 52 of Regulation No 1107/2009 provides for a simplified regime for plant protection products already authorised in another Member State.

28.      Indeed, as the Court had already held in relation to Directive 91/414 — which, as already mentioned, did not provide for such a regime — when a parallel import operation ‘relates to a plant protection product which has already been authorised in accordance with Directive 91/414 in the exporting Member State and in the importing Member State, that product cannot be regarded as being placed on the market for the first time in the importing Member State. It is not therefore necessary, for the purpose of protecting human and animal health and the environment, to make parallel importers subject to the marketing authorisation procedure laid down by that directive, given that the competent authorities in the importing Member State already have all the information necessary for the exercise of that scrutiny. To make the product to be imported subject to the marketing authorisation procedure would go beyond what is necessary to achieve the objectives of Directive 91/414 as to the protection of public and animal health and of the environment and may, without justification, run counter to the principle of the free movement of goods laid down in Article 34 TFEU’. (6) However, the Court nevertheless specified that ‘a plant protection product introduced into the territory of a Member State as a parallel import cannot, automatically or absolutely and unconditionally, have the benefit of a marketing authorisation issued to a plant protection product already on the market of that State. … Member States are required to subject plant protection products which are intended to be imported into their territory as parallel imports to an examination procedure, which can … take the form of a “simplified” procedure’. (7)

29.      It follows from this case-law that the key element which must guide the interpretation of the law on the placing of plant protection products on the market is clearly the balance which must be struck as between two objectives which may be contradictory, namely, the free movement of goods on the one hand and the protection of public and animal health and of the environment on the other.

30.      In that context, it must be noted, however, that it is the second objective which the Union legislator has — for perfectly understandable reasons — deemed to be the most important. That follows from the case-law — the Court having qualified the safeguarding of human and animal health and the environment as ‘the primary objective of EU legislation’ (8) — but also from the language of Regulation No 1107/2009 itself. Thus, recital 24 of Regulation No 1107/2009 states that ‘the provisions governing authorisation must ensure a high standard of protection. In particular, when granting authorisations of plant protection products, the objective of protecting human and animal health and the environment should take priority over the objective of improving plant production’. (9)

31.      In those circumstances, where the reference product itself is subject to a new authorisation after a full examination of the conditions laid down in Article 29 of Regulation No 1107/2009, it is clear that an automatic adaptation of the period of validity of the parallel trade permit would facilitate the freedom of movement of the goods concerned. Since, however, Regulation No 1107/2009 does not expressly provide for an automatic prolongation of the validity of the parallel trade permit ‘related’ to the reference product which is the subject of a new authorisation, the main objective of the safeguarding of human and animal health and of the environment does not allow such a prolongation of the parallel trade permit simply automatically to be presumed. (10)

32.      On the contrary, since the reference product itself has been subject to a new review, the objective of protecting human and animal health and the environment must accordingly prevail. In these circumstances, Union law envisages that a new decision will be taken following a simplified procedure in order to verify whether there is still an identity between the previous reference product subject to a new authorisation and the plant protection product subject to the parallel trade permit. In this respect, the conditions set out in Article 52(3) of Regulation No 1107/2009 are sufficient and respect the limits of what is necessary in order to achieve the aim of protection of the environment and of human and animal health that is legitimately being pursued.

33.      This interpretation of Regulation No 1107/2009 is also consistent with the need to ensure the effectiveness of the control mechanism which must be operated by Member States and which underpins the legislation on the placing of plant protection products on the market. (11)

34.      This interpretation is also underscored by the context of Regulation No 1107/2009. Indeed, Article 52(7) of Regulation No 1107/2009 provides that Articles 44 and 45 of this regulation must apply mutatis mutandis to parallel traded plant protection products. As Article 44(1) and Article 45(2) of Regulation No 1107/2009 refer to the requirements laid down in Article 29 of the same regulation — which is specific to the authorisation of the reference product — the corresponding conditions for the parallel trade permit, namely, the conditions set out in Article 52 of Regulation No 1107/2009, must be taken into account.

35.      In those circumstances, on the one hand, Article 44 allows Member States to review an authorisation, at any time, where there are indications that a requirement referred to by Article 52(3) of Regulation No 1107/2009 is no longer satisfied. On the other hand, Article 45 provides that an authorisation may be amended at the request of the holder of the authorisation where it is established that the requirements referred to in Article 52(3) of Regulation No 1107/2009 nonetheless continue to be met.

36.      In addition, it follows from those provisions that, while the holder of the parallel trade permit may, obviously, request the renewal of his permit on his or her own initiative, the competent authorities of Member States may also initiate the procedure themselves. In such a case, they must, in accordance with Article 44(2) of Regulation No 1107/2009, then inform the holder of the parallel trade permit and give him or her the possibility to submit comments or further information.

3.      Conclusion on the first four questions

37.      Accordingly, in the light of the foregoing considerations, I find myself concluding that the modification of the period of validity of a parallel trade permit granted on the basis of Article 52 of Regulation No 1107/2009 does not automatically follow from a decision to re-register the reference product. On the contrary, such a prolongation must be the subject of a decision by the competent authority following a procedure in which that authority verifies that the product for which a parallel trade permit was granted is still an identical product to the reference product, in accordance with the conditions imposed in Article 52(3) of Regulation No 1107/2009. This decision may be taken on the initiative of the competent authority or at the request of the holder of the parallel trade permit.

B.      The fifth, sixth and seventh questions

38.      The fifth, sixth and seventh questions all concern the conditions set out in Article 52(3) of Regulation No 1107/2009 to consider that a plant protection product is identical to the reference product and, more specifically, the obligation for plant protection products to ‘have been manufactured by the same company or by an associated undertaking or under licence in accordance with the same manufacturing process’. I will therefore examine these questions together.

1.      The origin of Article 52(3)(a) of Regulation No 1107/2009

39.      As already mentioned above, it is necessary, in interpreting a provision of EU law, to consider not only its wording but also its context and the objectives of the legislation of which it forms part, and, in particular, the origin of that legislation. (12)

40.      In that context, it is clear from the wording of Article 52(3) of Regulation No 1107/2009 that the conditions laid down by this provision are cumulative in nature. This is evidenced by the use of the conjunction ‘and’ between the conditions under Article 52(3)(b) and Article 52(3)(c) of the regulation. It is also plain that it is the plant protection product itself (or as such) — namely the whole product — which ‘ha[s] been manufactured by the same company or by an associated undertaking or under licence in accordance with the same manufacturing process’.

41.      Secondly, as I have explained in respect of the first four questions, Regulation No 1107/2009 pursues two objectives: 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. (13) However, the first condition required by Article 52(3)(a) has a specific objective which finds its origin in the case-law of the Court, whereas the applicable legislation did not contain any provision governing the conditions for the granting of marketing authorisations where there are parallel imports. (14)

42.      Indeed, even before the adoption of Regulation No 1107/2009, the Court had already held that, in order to benefit from the marketing authorisation already granted in the Member State of importation, a plant protection product imported should share at least, among others, with the product already authorised within the Member State of importation, a common origin, in the sense that the imported plant protection product ‘has been manufactured by the same company or by an associated undertaking or under licence according to the same formulation’. (15) It follows, nevertheless, from the same settled case-law that those products do not have to be identical in all respects. (16) In those circumstances, the Court ruled that a similar condition, which was laid down in the legislation of a Member State, did not necessarily constitute an obstacle to trade prohibited by Article 34 TFEU. (17)

43.      According to the Court, ‘that condition relating to the common origin of the relevant products allows cases of parallel importation to be identified and distinguished from other related situations in which the importation of a product requires a marketing authorisation and also constitutes an important indication that the imported product and the reference product are identical’. (18)

44.      It seems to me, therefore, that the origin of this condition, which is now formally laid down in Article 52(3)(a) of Regulation No 1107/2009, cannot lead to an interpretation that goes beyond what is necessary to demonstrate the common origin of the reference product and the plant protection product on pain of contradicting one of the general objectives of this regulation, by constituting an obstacle to the free movement of the products concerned.

2.      Interpretation of Article 52(3)(a) in relation to the present case

45.      With its fifth question, the referring court asks if a plant protection product can be considered not to be identical within the meaning of Article 52 of Regulation No 1107/2009 if the reference product does not (any longer) originate from the same undertaking and if 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 formulation and with the consent of the right-holder.

46.      It follows from the wording of Article 52(3)(a) of Regulation No 1107/2009 that two products can be identical even if they do not originate from the same undertaking since that provision expressly contemplates two other possibilities, it being understood that this is only when those products ‘were manufactured in parallel, by two competing undertakings, [that] the imported product must, at first sight, be regarded as separate from the reference product’. (19)

47.      To my mind, the words ‘under licence in accordance with the same manufacturing process’ found in Article 52(3)(a) of the Regulation No 1107/2009 can, without undue liberality, also be interpreted as including those circumstances where the plant protection products are manufactured using the same manufacturing process by a different entity with the consent of the right-holder, even if this arrangement is not as such pursuant to a formal licensing arrangement negotiated between the parties. It is true, however, as the Commission observed at the hearing on 13 May 2019, that there must be some degree of stability in the relationship between the parties. An isolated or purely ephemeral transaction would probably not suffice for this purpose.

48.      In those circumstances and in the light of the foregoing considerations, I consider that if the reference product — namely, the whole product — is manufactured by an undertaking using the same manufacturing process as the imported plant protection product, with the consent of the manufacturer of that product, both products must be considered as having the same origin within the meaning of Article 52(3)(a) of Regulation No 1107/2009.

49.      Similarly, the mere changing of the location for the production of the reference product or a change in the name of the product or a slight change in the composition of the reference product without any appreciable consequences in respect of the effects of the product is irrelevant if the whole product is still manufactured with the consent of the manufacturer of the imported plant protection product.

50.      Any other interpretation of Article 52(3)(a) of Regulation No 1107/2009 would, I think, go beyond what is necessary to guarantee the common origin of the two products — which is the particular objective of this provision — and, in so doing, run counter to the general objectives of Regulation No 1107/2009 which are health and environmental protection but also the free movement of products.

51.      By contrast, if, however, the manufacturing process has been substantially modified or even slightly modified — but this modification nonetheless has appreciable consequences in respect of the effects of the product — or is no longer used with the consent of the manufacturer of the imported plant protection product, the products must be considered to be separate. Indeed, in this case, the products must be considered as no longer having a common origin but manufactured in parallel by two competing undertakings.

3.      Conclusion on the fifth, sixth and seventh questions

52.      Accordingly, in the light of the foregoing considerations, I think that if the reference product — namely the whole product — is manufactured by an undertaking using the same manufacturing process as the imported plant protection product, with the consent of the manufacturer of that product as part of a stable business relationship, both products must then be considered as having the same origin within the meaning of Article 52(3)(a) of Regulation No 1107/2009. In that respect, the mere changing of the location for the production of the reference product or a change in the name of the product or a slight change in the composition of the reference product without appreciable consequences in respect of the effects of the product is irrelevant if the whole product is still manufactured with the consent of the manufacturer of the imported plant protection product.

C.      The eighth question

53.      By its eighth question, the referring court asks the Court on whom and to what extent does the burden of proof lie to show that Article 52(3) of Regulation 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.

54.      Since I have come to the conclusion that a new decision is required when the reference product is itself the subject of a new registration, it follows from Article 52(2) of that regulation that it is for the holder of the parallel product permit to produce a new ‘complete application’ (whether on its own initiative or at the request of the competent authority) (20) in order to demonstrate that the products concerned are still identical.

55.      In this respect, Article 52(4) of Regulation No 1107/2009 lists the information that the application for a parallel trade permit must contain. In addition, in accordance with Article 52(2) of Regulation No 1107/2009, the competent authority can request the Member State of origin of the imported product for the information necessary in order to assess whether the products are identical.

56.      For the rest, in the absence of EU rules concerning the procedural requirements attaching to the burden of proof in the examination of an application for a parallel trade permit, it is, according to established case-law, for the domestic legal system of each Member State to determine those requirements in accordance with the principle of procedural autonomy provided, however, that those requirements are not less favourable than those governing similar domestic situations (principle of equivalence) and that they do not render impossible in practice or excessively difficult the exercise of rights conferred by the EU legal order (principle of effectiveness). (21)

57.      As regards the principle of effectiveness, if the holder of the authorisation of the reference product contests the application of the holder of the parallel trade permit or the competent authority’s decision, it is his responsibility to substantiate these contentions. If it were otherwise, it would mean that such an applicant for a parallel trade permit would potentially be forced to provide evidence of elements that his products do not contain in regard to the reference product. In those circumstances, the exercise of the right to obtain a parallel trade permit conferred by EU law would, consequently, be rendered excessively difficult and, perhaps, even impossible.

58.      In this respect, it may be recalled that the competent authority of the Member State of importation must have at its disposal legislative and administrative means capable of compelling the manufacturer, his duly appointed representative or the licensee for the plant protection product already covered by a marketing authorisation to supply information in their possession which the authority considers to be necessary. (22)

59.      Accordingly, it is the responsibility of the applicant for the parallel permit to provide the information referred to in Article 52(4) of Regulation No 1107/2009 in order to demonstrate that the plant protection product fulfils the conditions laid down in Article 52(3) of Regulation No 1107/2009. This, of course, is entirely without prejudice to the possibility for the competent authority to collect from the Member State of origin the information necessary to assess the identical nature of the products concerned and to check whether those conditions are met. On the other hand, in the event of a possible complaint or appeal against the decision to issue a parallel trade permit, it is for the holder of the authorisation of the reference product to justify why his objections are well founded, in accordance with the principle of procedural autonomy.

VI.    Conclusion

60.      Accordingly, I propose that the Court should answer the questions referred by the College van Beroep voor het Bedrijfsleven (Administrative Court of Appeal for Trade and Industry, Netherlands) as follows:

(1)      The modification of the period of validity of a parallel trade permit granted on the basis of Article 52 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 does not automatically follow from a decision to re-register the reference product. On the contrary, such a prolongation must be the subject of a decision by the competent authority following a procedure in which that authority verifies that the product for which a parallel trade permit was granted is still an identical product to the reference product, in accordance with the conditions imposed in Article 52(3) of Regulation No 1107/2009. This decision may be taken on the initiative of the competent authority or at the request of the holder of the parallel trade permit.

(2)      If the reference product — namely the whole product — is manufactured by an undertaking using the same manufacturing process as the imported plant protection product, with the consent of the manufacturer of that product as part of a stable business relationship, both products must be considered as having the same origin within the meaning of Article 52(3)(a) of Regulation No 1107/2009. In that respect, the mere changing of the location for the production of the reference product or a change in the name of the product or a slight change in the composition of the reference product without appreciable consequences in respect of the effects of the product is irrelevant if the whole product is still manufactured with the consent of the manufacturer of the imported plant protection product.

(3)      It is the responsibility of the applicant for the parallel permit to provide the information referred to in Article 52(4) of Regulation No 1107/2009 in order to demonstrate that the plant protection product fulfils the conditions laid down in Article 52(3) of Regulation No 1107/2009, without prejudice to the possibility for the competent authority to collect from the Member State of origin the information necessary to assess the identical nature of the products concerned and to check whether those conditions are met. On the other hand, in the event of a possible complaint or appeal against the decision to issue a parallel trade permit, it is for the holder of the authorisation of the reference product to justify why his objections are well founded, in accordance with the principle of procedural autonomy.

1      Original language: English.

2      OJ 2009 L 309, p. 1.

3      Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ 1991 L 230, p. 1).

4      See, to that effect, judgment of 6 November 2014, Mac (C‑108/13, EU:C:2014:2346, paragraph 27 and the case-law cited).

5      See, for recent applications, judgments of 17 April 2018, Egenberger (C‑414/16, EU:C:2018:257, paragraph 44), and of 26 February 2019, Rimšēvičs and ECB v LatviaRimšēvičs and ECB v LatviaRimšēvičs and ECB v Latvia (C‑202/18 and C‑238/18, EU:C:2019:139, paragraph 45).

6      Judgment of 6 November 2014, Mac (C‑108/13, EU:C:2014:2346, paragraph 27 and the case-law cited).

7      Judgment of 6 November 2014, Mac (C‑108/13, EU:C:2014:2346, paragraphs 29 and 30). See also judgment of 8 November 2007, Escalier and Bonnarel (C‑260/06 and C‑261/06, EU:C:2007:659, paragraphs 30 and 32).

8      ‘While it is for the national authorities to ensure that the primary objective of EU legislation, namely the safeguarding of human and animal health and the environment, is strictly observed, the principle of proportionality nevertheless requires that, in order to protect the free movement of goods, the legislation in question be applied within the limits of what is necessary in order to achieve the aim of protection of the environment and of human and animal health that is legitimately being pursued’ (judgment of 6 November 2014, Mac, C‑108/13, EU:C:2014:2346, paragraph 39, emphasis added).

9      Emphasis added. See also recitals 8, 25, 29 or 33.

10      On the contrary, Article 52(6) of Regulation No 1107/2009 provides that ‘if the authorisation holder of the reference product applies for a withdrawal of authorisation in accordance with Article 45(1) and the requirements of Article 29 are still fulfilled, the validity of the parallel trade permit shall expire by the date on which the authorisation of the reference product would normally have expired’ (emphasis added).

11      See, to that effect, judgment of 8 November 2007,Escalier and Bonnarel (C‑260/06 and C‑261/06, EU:C:2007:659, paragraph 35).

12      See, for recent applications, judgments of 17 April 2018, Egenberger (C‑414/16, EU:C:2018:257, paragraph 44), and of 26 February 2019, Rimšēvičs and ECB v LatviaRimšēvičs and ECB v LatviaRimšēvičs and ECB v Latvia (C‑202/18 and C‑238/18, EU:C:2019:139, paragraph 45).

13      See Article 1(3) of Regulation No 1107/2009.

14      See, to that effect, judgments of 11 March 1999, British Agrochemicals Association (C‑100/96, EU:C:1999:129, paragraphs 33 and 40); of 21 February 2008, Commission v FranceCommission v FranceCommission v France(C‑201/06, EU:C:2008:104, paragraphs 39 and 43); and of 6 November 2014, Mac (C‑108/13, EU:C:2014:2346, paragraph 24).

15      See, to that effect, judgments cited in the previous note.

16      See, to that effect, judgments of 11 March 1999, British Agrochemicals Association (C‑100/96, EU:C:1999:129, paragraphs 33 and 40), and of 21 February 2008, Commission v FranceCommission v FranceCommission v France(C‑201/06, EU:C:2008:104, paragraph 39).

17      See, to that effect, judgment of 21 February 2008, Commission v FranceCommission v FranceCommission v France(C‑201/06, EU:C:2008:104, paragraph 42).

18      Judgment of 21 February 2008, Commission v FranceCommission v FranceCommission v France(C‑201/06, EU:C:2008:104, paragraph 43).

19      Judgment of 21 February 2008, Commission v FranceCommission v FranceCommission v France(C‑201/06, EU:C:2008:104, paragraph 43).

20      See developments above relating to the first four questions.

21      See, to that effect, judgment of 22 February 2018, INEOS Köln (C‑572/16, EU:C:2018:100, paragraph 42).

22      See, to that effect, judgment of 11 March 1999, British Agrochemicals Association (C‑100/96, EU:C:1999:129, paragraph 34).

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