Date: 2023-03-10Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2023/543 of 9 March 2023 amending Implementing Regulation (EU) No 686/2012 as regards the allocation to Member States, for the purposes of the renewal procedure, of the evaluation of active substances whose approval expires between 31 January 2029 and 1 October 2035 (Text with EEA relevance)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Implementing Regulation (EU) 2023/543 amends Implementing Regulation (EU) No 686/2012, allocating Member States for evaluating active substances in plant protection products. This allocation concerns substances whose approval expires between January 31, 2029, and October 1, 2035. The regulation aims to distribute responsibilities and workload among Member States for the renewal procedure. It enters into force on the twentieth day following its publication in the Official Journal of the European Union.
Key Points / Main Content:
* **Amendment of Implementing Regulation (EU) No 686/2012:**
* The regulation is amended to allocate the evaluation of active substances to specific Member States.
* Part E is added to the Annex of Implementing Regulation (EU) No 686/2012, listing active substances and their allocated Rapporteur and Co-rapporteur Member States.
* **Allocation of Active Substance Evaluation:**
* Specific active substances are assigned to a Rapporteur Member State and a Co-rapporteur Member State for evaluation.
* The allocation covers active substances whose approval expires between January 31, 2029, and October 1, 2035.
Impact Analysis:
* **Member States:**
* Impact: Member States are assigned responsibilities for evaluating specific active substances. Some Member States are designated as Rapporteur, while others are Co-Rapporteur.
* Action Required: Rapporteur and Co-rapporteur Member States must prepare for and conduct the evaluation of their assigned active substances within the framework of the renewal procedure.
* **European Commission:**
* Impact: The Commission oversees the implementation of the regulation and ensures the proper allocation of responsibilities.
* Action Required: The Commission must monitor the evaluation process and ensure compliance with the regulation.
* **Manufacturers/Producers of Active Substances:**
* Impact: Manufacturers are indirectly impacted as the regulation defines the evaluation process for their products, which will impact continued approval of their products in the EU.
* Action Required: Monitor the progress of the evaluations performed by Member States.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An institution of the European Union, responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
Treaty on the Functioning of the European Union: One of the two primary treaties upon which the European Union is founded.
Regulation (EC) No 1107/2009: Regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market.
Ursula VON DER LEYEN: The President of the European Commission.
Implementing Regulation (EU) No 686/2012: Commission Implementing Regulation allocating to Member States, for the purposes of the renewal procedure, the evaluation of the active substances.
Standing Committee on Plants, Animals, Food and Feed: A committee whose opinion is in accordance with the measures provided for in the regulation.
Brussels: City in Belgium; where the regulation was adopted.
10.3.2023 EN Official Journal of the European Union L 73/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION IMPLEMENTING REGULATION (EU) 2023/543
of 9 March 2023
amending Implementing Regulation (EU) No 686/2012 as regards the allocation to Member States,
for the purposes of the renewal procedure, of the evaluation of active substances whose approval
expires between 31 January 2029and 1 October 2035
(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 active substances to a
rapporteur Member State and to a co-rapporteur Member State for the purposes of the renewal procedure. Since the
evaluation of active substances whose approval expires between 31 January 2029and 1 October 2035has not yet
been allocated to a Member State or to a co-rapporteur Member State, it is appropriate to proceed to such allocation.
(2) That allocation should be made in a way that ensures a balance between Member States as regards the distribution of
the responsibilities and the work.
(3) Implementing Regulation (EU) No 686/2012 should therefore be amended accordingly.
(4) 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
Implementing Regulation (EU) No 686/2012 is amended in accordance with the Annex to this Regulation.
(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).L 73/2 EN Official Journal of the European Union 10.3.2023
Article 2
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, 9 March 2023.
For the Commission
The President
Ursula VON DER LEYEN10.3.2023 EN Official Journal of the European Union L 73/3
ANNEX
In the Annex to Implementing Regulation (EU) No 686/2012, the following Part E is added:
‘PART E
Allocation of the evaluation of active substances whose approval expires between 31 January 2029and
1 October 2035
Rapporteur Member Co-rapporteur Member
Active substance
State State
1-methylcyclopropene DE EL
2,4-D DE EL
2,4-DB EL IE
ABE-IT 56 FR PT
Acetamiprid DE ES
Acibenzolar-S-methyl ES BE
Ampelomyces quisqualis strain AQ10 SE NL
Bacillus amyloliquefaciens strain FZB24 DE AT
Bacillus subtilis strain IAB/BS03 ES AT
Beauveria bassiana strain 203 DK NL
Beauveria bassiana strain IMI389521 SE NL
Beauveria bassiana strain PPRI 5339 SE NL
Benzoic acid HU CZ
Carfentrazone-ethyl FR DE
Carvone IT NL
Cerevisane ES DE
Clonostachys rosea strain J1446 HU AT
Coniothyrium minitans strain CON/M/91-08 AT EE
COS-OGA FR HR
Cyhalofop-butyl CZ BE
Cypermethrin CZ DE
Dimethenamid-P BE DE
Ethofumesate AT FI
Fenhexamid BE CZ
Ferric phosphate PL DK
Ferric pyrophosphate CZ FR
Flazasulfuron ES PL
Florasulam CZ FR
Florpyrauxifen-benzyl FR IT
Flutianil DE EL
Foramsulfuron FR SK
Forchlorfenuron ES BEL 73/4 EN Official Journal of the European Union 10.3.2023
Iodosulfuron BE FR
Iprovalicarb SE LV
Isaria fumosorosea strain Apopka 97 NL AT
Isoxaflutole SE BE
Laminarin EL FR
Lavandulyl senecioate SE NL
Maleic hydrazide SI IT
Mefentrifluconazole ES FR
Mesosulfuron PL SE
Mesotrione NL SK
Metalaxyl-M DE EL
Mild Pepino Mosaic Virus isolate VC 1 FR DE
Mild Pepino Mosaic Virus isolate VX 1 FR DE
Pasteuria nishizawae Pn1 NL DK
Pepino mosaic virus strain CH2 isolate 1906 FI BE
Pethoxamid AT FR
Phlebiopsis gigantea strain FOC PG 410.3 EE FI
Phlebiopsis gigantea strain VRA 1835 EE FI
Phlebiopsis gigantea strain VRA 1984 EE FI
Picolinafen LT IT
Propoxycarbazone SE BE
Pyraflufen-ethyl DE FR
Pyridate AT DE
Pyriproxyfen ES BE
Saccharomyces cerevisiae strain LAS02 EL AT
Silthiofam NL IE
Sodium hydrogen carbonate AT FR
Sulfosulfuron IE SE
Thiabendazole NO ES
Thifensulfuron-methyl FR DK
Tolclofos-methyl FI SE
Tribenuron FR SE
Trichoderma atroviride strain SC1 SI NL
Trifloxystrobin HR DE
Verticillium albo-atrum strain WCS850 NL SE
Zoxamide BE PL’