In November 2016, the Administrative Court of Braunschweig issued a landmark ruling on the mutual recognition procedure according to Article 40 et seq. Regulation (EC) No. 1107/2009 (Administrative Court of Braunschweig, Judgements of 30 November 2016, 9 A 27/16 and 9 A 28/16). Recently the court issued a further landmark ruling on the system of zonal authorisation according to Article 36 Regulation (EC) No. 1107/2009 (Administrative Court of Braunschweig, Judgement of 12 April 2018, 9 A 44/16). In addition to some questions of procedural law, the system of zonal authorisation in particular was specified in more detail.
Zonal Authorisation Procedure
The court stresses, that in the zonal authorisation procedure, the applicant proposes to the Member States of a zone which Member State (so called zonal Rapporteur Member State or zRMS) should examine the application. If this proposal is complied with, the applicant shall apply to that Member State for a zonal authorisation and indicate in which other Member States of the zone he also intends to apply for authorisation (Article 35 Regulation (EC) No. 1107/2009). The other Member States within the zone to which an application is to be submitted are the so called concerned Member States (cMS). In addition to the application to the zRMS, the applicant submits the application for admission to all cMS simultaneously. Documents to be attached to the application are listed in Article 33 Regulation (EC) No. 1107/2009.
The application is then examined by the zRMS in accordance with Article 35 (1) Regulation (EC) No. 1107/2009. According to Article 36 (1) Regulation (EC) No. 1107/2009 the zRMS shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge on the basis of all guidance documents available at the time of application. It shall apply the uniform principles for evaluation and authorisation of plant protection products, referred to in Article 29 (6) Regulation (EC) No. 1107/2009, to establish, as far as possible, whether the plant protection product meets the requirements provided for in Article 29 Regulation (EC) No. 1107/2009 in the same zone, where used in accordance with Article 55 Regulation (EC) No. 1107/2009, and under realistic conditions of use.
According to Article 35 sentence 4 Regulation (EC) No. 1107/2009 the cMS shall refrain from proceeding with the file pending assessment by the zRMS. The zRMS shall then, in the course of the evaluation, prepare a draft Registration Report (dRR) in a format agreed between the Member States. This draft will then be sent to all Member States of the zone for comment (Article 36 (1) sentence 2 Regulation (EC) No. 1107/2009). At the end of the commenting period, the zRMS draws up the Final Registration Report (RR) taking into account the comments of the Member States and decides on the authorisation of the respective plant protection product. Then the zRMS sends the Final Registration Report and its admission decision to the other Member States in the same zone. The cMS shall at the latest within 120 days of the receipt of the assessment report and the copy of the authorisation of the zRMS decide on the application as referred to Article 36 (2) and (3) Regulation (EC) No. 1107/2009 (see Article 37 (4) Regulation (EC) No. 1107/2009).
The court stresses that according to Article 34 (4) Regulation (EC) No. 1107/2009 the 120-days-deadline begins with the receipt of the assessment report and the copy of the authorisation of the zRMS, rather than upon receipt of a translation of the authorisation in German, as this is not a mandatory part of the documents to be submitted within the framework of the zonal authorisation procedure.
Please be aware, that this is different in the mutual recognition procedure according to Article 40 Regulation (EC) No. 1107/2009. According to Article 42 (1) lit. a) Regulation (EC) No. 1107/2009 in the procedure of mutual recognition the applicant shall provide a copy of the authorisation granted by the reference Member State as well as a translation of the authorisation into an official language of the Member State receiving the application. In Germany, a translation into German is generally required because according to Section 23 Administrative Procedure Act (VwVfG) the official language is German. However, the BVL currently also accepts a translation into English. Please be aware, that this may change in the future.
No reason for refusal according to Article 36 (3) Regulation (EC) No. 1107/2009
The court clarifies, that the applicant has not automatically a right to claim an authorisation solely with expiry of the 120-day period of Article 37 (4) Regulation (EC) No. 1107/2009. The legislator has not attached a specific legal consequence to a Member State of the European Union exceeding the specified processing deadline. Accordingly, the expiry of the period may not give rise to any claim for authorisation or preclusion on the part of the Member State for reasons which it has not invoked within the period. Failure to reach a decision on an application in due time may at best be relevant for asserting a claim for damages due to loss of profit.
However, a claim arises from the fact that the requirements of Article 36 (3) Regulation (EC) No. 1107/2009 are not applicable. According to Article 36 (2) Regulation (EC) No. 1107/2009 the cMS shall grant or refuse authorisations on the basis of the conclusions of the assessment of the zRMS. Notwithstanding Article 36 (2) Regulation (EC) No. 1107/2009 and subject to the Community law, appropriate conditions may be laid down with regard to the requirements referred to in Article 31 (3) and (4) and other risk mitigation measures derived from the specific conditions of use. Where the concerns of a Member State relating to human or animal health or the environment cannot be controlled by the establishment of the national risk mitigation measures, a Member State may refuse authorisation of the plant protection product in its territory if, due to its specific environmental or agricultural circumstances, it has legitimate reasons to assume that the product in question still poses an unacceptable risk to human or animal health or the environment.
Limited scope of cMS audits
The court makes it clear, that according to Article 36 (2) Regulation (EC) No. 1107/2009 the cMS is obliged, with the exception of cases within the meaning of Article 36 (3) Regulation (EC) No. 1107/2009, to grant or refuse authorisations on the basis of the conclusions of the assessment by the zRMS. In principle, the cMS has no further competence to examine the decision of the zRMS. Germany, as cMS, is therefore neither authorised nor obliged to check the legality of the reference authorisation. This already follows from the wording of Article 36 (2) Regulation (EC) No. 1107/2009, which expressly stipulates that the cMS grant or refuse authorisations on the basis of the conclusions of the assessment by the zRMS. The Regulation (EC) No. 1107/2009 does not provide for the possibility of an examination going beyond the examination competence referred to in Article 36 (3) Regulation (EC) No. 1107/2009. It would have been up to the legislator to standardise further examination competence for the cMS, but it did not make use of this. The purpose of the zonal authorisation procedure is precisely to ensure that the cMS involved do not carry out their own examination of all the conditions for authorisation, but base their own decision on the examination already carried out by the zRMS. According to the recitals and the purpose of Regulation (EC) No. 1107/2009, its purpose is not only to provide a high level of protection for human and animal health and the environment, but also to ensure the competitiveness of agriculture, to harmonise authorisation practices within the Community, and to accelerate and improve efficiency.
The common European system for the authorisation of plant protection products is based on the principle of mutual trust in so far as all countries involved respect the requirements laid down in Regulation (EC) No. 1107/2009 and ensure a high level of protection. This leads to the assumption that the processing of applications for authorisation for plant protection products in each Member State complies with the requirements of the Regulation (EC) No. 1107/2009. The purposes of the Regulation would not be achieved if the cMS would or should carry out a full legality check of the reference authorisation.
The court makes it clear, that the exceptions set out in Article 36 (3) Regulation (EC) No. 1107/2009 are the only grounds on which a cMS can rely in order to refuse the recognition of an authorisation granted by the zRMS. The zonal authorisation procedure therefore leaves no room for refusal to authorise a plant protection product for reasons other than those mentioned in Article 36 (3) Regulation (EC) No. 1107/2009.
No committal in case of systematic violations
However, the presumption that the processing of applications for authorisation for plant protection products in each Member State complies with the requirements of Regulation (EC) No. 1107/2009 can be rebutted. A rebuttal of the presumption, however, is made extremely difficult due to the important purposes of the Common European System. Therefore, not every deficient examination and not every infringement of the requirements of Regulation (EC) No. 1107/2009 is sufficient to confer examination competence on the cMSs. In any case, as long as it does not appear that a reference Member State systematically violates the legal provisions to be observed in the respective authorisation procedure, there is no room for a further review in the national authorisation procedure.
Please be aware, that Germany is already collecting respective violations by other Member States.
Refusal according to Article 36 (3) Regulation (EC) No. 1107/2009
The court stresses, that a refusal according to Article 36 (3) Regulation (EC) No. 1107/2009 should be an exceptional ultima ratio. For a refusal of an authorisation, all conditions of Article 36 (3) Regulation (EC) No. 1107/2009 must be fulfilled. In particular, risk mitigation measures should be examined. A total refusal is therefore only possible if the establishment of such risk mitigation measures cannot address the existing concerns with regard to human or animal health or the environment. The refusal of authorisation can only be justified in the light of “specific environmental or agricultural circumstances”. In addition, the Member State must have “legitimate reasons to assume” that the product in question still poses an “unacceptable risk” to human or animal health or the environment.
Regarding the criterion for the risk assessment, the court stresses that the cMS must have legitimate reasons to assume that the product in question still poses an “unacceptable risk” to human or animal health or the environment. For this, it is not necessary to prove that unacceptable risks exist, only to present a "legitimate reason to assume" that they do. However, a legitimate reason for such an assumption is more than just a mere presumption. The exceptional provision of Article 36 (3) Regulation (EC) No. 1107/2009 cannot already be used in cases of suspicion and an uncertain scientific basis. Fears and suspicions alone are not enough. The identification of a potential risk, which ultimately has not yet been examined in studies, does not reach the threshold of a “legitimate reason to assume that unacceptable risks exist”. If an authorisation has been granted by the zRMS, the deviation from this fundamental decision cannot be made on the basis of suspicion and reference to data gaps. Any data gaps cited by cMS that prevent a more precise risk assessment (to the extent of identifying legitimate reasons for unacceptable risks) must be closed by the Member State that relies on the exemption in Article 36 (3) 2 Regulation (EC) No. 1107/2009. Even if the precautionary principle pursuant to Article 1 (4) of Regulation (EC) No. 1107/2009 applies in an authorisation procedure, the exception is not to be interpreted in such a way that the possibility of an unacceptable risk should already be ruled out by the refusal of authorisation.
In addition, the court clarifies that the high hurdles of the exceptional circumstances cannot ultimately be cancelled out by the zRMS itself by any opening clauses and the transfer of further examination competences. The scope of the examination competences under the Regulation is not in the hands of the zRMS. However, such a "transfer of examination competences" could warrant a further examination of the authorisation if a systematic deficiency is identified therein (see point 4). In any case, however, as long as it does not suggests itself that a zRMS systematically violates the legal provisions to be observed in the respective authorisation procedure, there is no scope for further review in the national authorisation procedure.
Action for failure to act: No justification for inaction
In addition, the court clarifies the legal situation concerning the filing of actions for failure to act against the BVL for failure to comply with the time limits according to Article 37 (4) Regulation (EC) No. 1107/2009. Pursuant to Section 75 German Rules of Administrative Courts (VwGO), the action shall be admissible if an application to carry out an administrative act has not been decided on the merits within a suitable period without sufficient reason. The action may not be lodged prior to the expiry of three months after the lodging of the objection or since the filing of the application to carry out the administrative act, unless a shorter period is required because of special circumstances of the case.
The court now expressly clarifies that the outstanding agreement of UBA does not constitute sufficient grounds within the meaning of Section 75 (1) VwGO. A reason can only be "sufficient" in this sense if it is in accordance with the legal system. Article 37 (4) Regulation (EC) No. 1107/2009 determines the appropriate time limit for processing the application for authorisation. The cMS shall decide on the application at the latest within 120 days of the receipt of the assessment report and the copy of the authorisation of the zRMS.
It is irrelevant here that the BVL may not have decided on the application within the decision deadline only because the UBA has not yet reached an agreement. Whether and which possibilities the BVL may have to ignore an unlawfully withheld or failed agreement of the UBA is irrelevant to the question of the unlawfulness of the withholding of the authorisation. The question of unlawfully refused agreement is only an administrative, internal matter for which the BVL is responsible to the applicant in its external relations. The lack of agreement of the participation authority is of no importance for the court's decision on an obligation claim, as it is only an internal administrative issue. The BVL cannot effectively withdraw in court on a failed or withheld agreement.
The decision is a further landmark ruling. The court specifies the responsibilities of the zRMS and the involved cMS in more detail. The principles developed for the mutual recognition procedure are now expressly transferred to the zonal authorisation procedure. In addition, the rights of applicants will be further strengthened. Even if the court did not comment on whether the BVL is entitled and obliged to carry out the examination itself in place of the UBA in the event of a dispute, it did state expressly that whether and which possibilities the BVL may have to ignore an unlawfully withheld or failed agreement of the UBA is irrelevant for the question of the unlawfulness of the withholding of the authorisation. It remains to be seen whether the BVL will change its administrative practice in the event of a missing or outstanding agreement by an involved authority.
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