Commission Implementing Regulation (EU) 2019/724 of 10 May 2019 amending Implementing Regulation (EU) No 686/2012 as regards the nomination of rapporteur Member States and co-rapporteur Member States for the active substances glyphosate, lambda-cyhalothrin, imazamox and pendimethalin and amending Implementing Regulation (EU) No 844/2012 as regards the possibility that a group of Member States assumes jointly the role of the rapporteur Member State (Text with EEA relevance.)
Date: 2019-05-10
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: France, Greece, Hungary, Italy, Netherlands, Sweden, market approval, plant health control, plant health product




L_2019124EN.01003201.xml










13.5.2019   


EN


Official Journal of the European Union


L 124/32








            COMMISSION IMPLEMENTING REGULATION (EU) 2019/724
of 10 May 2019
         
amending Implementing Regulation (EU) No 686/2012 as regards the nomination of rapporteur Member States and co-rapporteur Member States for the active substances glyphosate, lambda-cyhalothrin, imazamox and pendimethalin and amending Implementing Regulation (EU) No 844/2012 as regards the possibility that a group of Member States assumes jointly the role of the rapporteur Member State
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,


Having regard to 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 (1), and in particular Article 19 thereof,

Whereas:







(1)


Commission Implementing Regulation (EU) No 686/2012 (2) allocates the evaluation of an active substance to a rapporteur Member State and to a co-rapporteur Member State for the purposes of the renewal procedure. Since the evaluations of the active substances glyphosate, imazamox and pendimethalin have not yet been allocated to a rapporteur Member State or to a co-rapporteur Member State and their approval expires between 1 January 2022 and 31 December 2024, it is appropriate to proceed with such allocation.












(2)


That allocation should be made in such a way that a balance is achieved as regards the distribution of the responsibilities and the work between Member States.












(3)


In exceptional cases, the expected workload and the complexity related to the evaluation of a specific active substance might exceed the capacities of a single Member State as a rapporteur supported by a single co-rapporteur Member State. In these cases, a broader repartition of the workload and a pooling of expertise of several Member States may be warranted by designating a group of Member States acting jointly as rapporteur Member State. It should therefore be clarified that it is possible that the role of the rapporteur Member State can be assumed jointly by a group of Member States. In this case, an appointment of a co-rapporteur Member State is not needed. Accordingly, where several Member States perform jointly the role as rapporteur Member State, they should agree on the modalities of the work organisation. Against this background, the evaluation of the active substance glyphosate should be allocated to a group of Member States acting jointly as rapporteur Member State.












(4)


For imazamox the evaluation should be allocated to Greece as rapporteur Member State and to Italy as co-rapporteur Member State.












(5)


For pendimethalin the evaluation should be allocated to Sweden as rapporteur Member State and to the Netherlands as co-rapporteur Member State.












(6)


In agreement with the Member States concerned, it is also considered necessary to change the rapporteur Member State for the active substance lambda-cyhalothrin while respecting the balance as regards the distribution of the responsibilities and the work between Member States. The evaluation for the purposes of the renewal procedure for lambda-cyhalothrin should be allocated to Greece as rapporteur Member State, while the allocation to France as co-rapporteur remains unchanged.












(7)


Commission Implementing Regulation (EU) No 844/2012 (3) provides for the implementation of the renewal procedure for active substances as provided for in Regulation (EC) No 1107/2009.












(8)


Implementing Regulation (EU) No 844/2012 provides for the handling of applications and the subsequently submitted supplementary dossiers and their assessment by one Member State as rapporteur Member State supported by one Member State acting as co-rapporteur Member State. However, the procedural modalities should be clarified for the exceptional cases referred to above, where the evaluation is allocated to a group of Member States acting jointly as rapporteur Member State in accordance with Implementing Regulation (EU) No 686/2012. This group should jointly assume the role given to the rapporteur Member State by Implementing Regulation (EU) No 844/2012.












(9)


The possibilities to require fees and charges in accordance with Article 74 of Regulation (EC) No 1107/2009 should be clarified for the renewal procedure.












(10)


Implementing Regulations (EU) No 686/2012 and (EU) No 844/2012 should therefore be amended accordingly.












(11)


The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,





HAS ADOPTED THIS REGULATION:



Article 1

Amendments to Implementing Regulation (EU) No 686/2012

Implementing Regulation (EU) No 686/2012 is amended as follows:






(1)


Article 1 is replaced by the following:

‘Article 1
For the purposes of the renewal procedure, the evaluation of each active substance set out in the first column of the Annex is allocated either to a rapporteur Member State, as set out in the second column of that Annex, and to a co-rapporteur Member State, as set out in the third column of that Annex, or to a group of Member States acting jointly as rapporteur Member State, as set out in the fourth column of that Annex, where applicable. In the latter case, no co-rapporteur is appointed.’











(2)


The Annex is amended in accordance with the Annex to this Regulation.






Article 2

Amendments to Implementing Regulation (EU) No 844/2012

Implementing Regulation (EU) No 844/2012 is amended as follows:






(1)


Paragraph 1 of Article 1 is amended as follows:






(a)


the first subparagraph is replaced by the following:
‘Without prejudice to the fourth subparagraph, an application for the renewal of an approval of an active substance shall be submitted by a producer of the active substance to the rapporteur Member State, as set out in the second column of the Annex to Commission Implementing Regulation (EU) No 686/2012 (*1) and to the co-rapporteur Member State as set out in the third column of that Annex, or to each of the Member States in a group of Member States acting jointly as rapporteur Member State as set out in the fourth column of that Annex, no later than three years before the expiry of the approval.

(*1)  Commission Implementing Regulation (EU) No 686/2012 of 26 July 2012 allocating to Member States, for the purposes of the renewal procedure, the evaluation of the active substances (OJ L 200, 27.7.2012, p. 5).’;"
                        










(b)


the following fourth, fifth and sixth subparagraphs are added:
‘Where a group of Member States jointly assumes the role of the rapporteur Member State as set out in the fourth column of the Annex to Implementing Regulation (EU) No 686/2012, no co-rapporteur Member State shall be appointed. In this case, all references to “the rapporteur Member State” in this Regulation shall be deemed to be references to “the group of Member States acting jointly as rapporteur Member State”.
Prior to the expiry of the deadline for submission of the application, the Member States acting jointly as rapporteur Member State shall agree on the repartition of all tasks and workload.
Member States forming part of the group of Member States acting jointly as rapporteur Member State shall endeavour to reach consensus during the evaluation.’;














(2)


in Article 11(2), point (h) is replaced by the following:






‘(h)


the points on which the co-rapporteur Member State did not agree with the assessment by the rapporteur Member State, where relevant, or, where applicable, the points where there is no agreement between Member States forming a group of Member States acting jointly as rapporteur Member State.’;














(3)


the following Article 13a is inserted:

‘Article 13a
Fees and charges
Member States may require payment of fees and charges in accordance with Article 74 of Regulation (EC) No 1107/2009 to recover the costs associated with any work they carry out within the scope of this Regulation.’







Article 3

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 May 2019.


For the Commission


The President

Jean-Claude JUNCKER
            





(1)  
            OJ L 309, 24.11.2009, p. 1.

(2)  Commission Implementing Regulation (EU) No 686/2012 of 26 July 2012 allocating to Member States, for the purposes of the renewal procedure, the evaluation of the active substances (OJ L 200, 27.7.2012, p. 5).

(3)  Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).




ANNEX
The Annex to Implementing Regulation (EU) No 686/2012 is amended as follows:






(1)


in Part B, the following fourth column is added with the heading:

                        ‘Group of Member States acting jointly as rapporteur Member State (in alphabetical order in national language)’;










(2)


Part C is amended as follows:






(a)


the following fourth column is added with the heading: ‘Group of Member States acting jointly as rapporteur Member State (in alphabetical order in national language)’;










(b)


the following entry is inserted after the entry for Geraniol:








Active substance


Rapporteur Member State


Co-rapporteur Member State


Group of Member States acting jointly as rapporteur Member State (in alphabetical order in national language)




‘Glyphosate


 


 


FR, HU, NL, SE’














(c)


the following entry is inserted after the entry for Helicoverpa armigera nucleopolyhedrovirus (HearNPV):








Active substance


Rapporteur Member State


Co-rapporteur Member State


Group of Member States acting jointly as rapporteur Member State (in alphabetical order in national language)




‘Imazamox


EL


IT’


 














(d)


the entry for the active substance lambda-cyhalothrin is replaced by the following:








Active substance


Rapporteur Member State


Co-rapporteur Member State


Group of Member States acting jointly as rapporteur Member State (in alphabetical order in national language)




‘lambda-cyhalothrin


EL


FR’


 














(e)


the following entry is inserted after the entry for Paecilomyces fumosoroseus strain Fe9901:








Active substance


Rapporteur Member State


Co-rapporteur Member State


Group of Member States acting jointly as rapporteur Member State (in alphabetical order in national language)




‘Pendimethalin


SE


NL’