Date: 2022-05-16Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2022/740 of 13 May 2022 concerning the non-approval of the active substance 1,3-dichloropropene, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Implementing Regulation (EU) 2022/740 addresses the non-approval of the active substance 1,3-dichloropropene, in accordance with Regulation (EC) No 1107/2009. This decision follows a risk assessment that identified potential concerns for human and animal health and the environment. The regulation came into force on the twentieth day following its publication in the Official Journal of the European Union.
Key Points / Main Content:
* **Non-Approval:**
* The active substance 1,3-dichloropropene is not approved.
* **Application History:**
* Dow AgroSciences and Kanesho Soil Treatment SPRLBVBA submitted an application for approval to Spain on March 2, 2015.
* The rapporteur Member State notified the admissibility of the application on July 7, 2015.
* The applicants withdrew their application for approval on January 19, 2022.
* **Risk Assessment Concerns:**
* The European Food Safety Authority (EFSA) could not finalize the risk assessment for consumers, operators, workers, bystanders, and residents.
* Potential concerns were identified for groundwater, non-target arthropods (including bees), birds, mammals, and soil organisms.
* **Future Applications:**
* The Regulation does not prevent the submission of further applications for approval of 1,3-dichloropropene.
* **Entry into Force:**
* The regulation entered into force on the twentieth day following its publication in the Official Journal of the European Union.
Impact Analysis:
* **Applicants (Dow AgroSciences and Kanesho Soil Treatment SPRLBVBA):**
* Impact: Their application for approval of 1,3-dichloropropene has been denied.
* Action Required: Cease any activities relying on the approval of this substance; may submit a new application in the future.
* **Member States:**
* Impact: Must implement the non-approval of 1,3-dichloropropene within their jurisdictions.
* Action Required: Ensure that plant protection products containing 1,3-dichloropropene are not placed on the market.
* **European Commission:**
* Impact: Responsible for enforcing the regulation across the European Union.
* Action Required: Monitor compliance and consider any future applications for approval of the substance.
* **Plant Protection Product Manufacturers/Distributors:**
* Impact: Cannot place plant protection products containing 1,3-dichloropropene on the market.
* Action Required: Ensure compliance with the regulation.
* **Farmers/Users of Plant Protection Products:**
* Impact: Cannot use plant protection products containing 1,3-dichloropropene.
* Action Required: Find alternative solutions for plant protection.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
Regulation EC No 1107/2009: Regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market.
European Parliament: The parliamentary body of the European Union.
Council of the European Union: A legislative body of the European Union comprising government ministers from each member state.
1,3-dichloropropene: An active substance used in plant protection products, the non-approval of which is the subject of this regulation.
European Food Safety Authority: An agency of the European Union that provides independent scientific advice on food safety.
Dow AgroSciences: One of the applicants for the approval of the active substance 1,3-dichloropropene.
Spain: The rapporteur Member State to which Dow AgroSciences and Kanesho Soil Treatment SPRLBVBA submitted the application for the approval of 1,3dichloropropene
L 137/10 EN Official Journal of the European Union 16.5.2022
COMMISSION IMPLEMENTING REGULATION (EU) 2022/740
of 13 May 2022
concerning the non-approval of the active substance 1,3-dichloropropene, in accordance with
Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the
placing of plant protection products on the market
(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 13(2) thereof,
Whereas:
(1) On 2 March 2015, Dow AgroSciences and Kanesho Soil Treatment SPRL/BVBA submitted to Spain (‘the rapporteur
Member State’) an application for the approval of the active substance 1,3-dichloropropene pursuant to Article 7(1)
of Regulation (EC) No 1107/2009.
(2) Pursuant to Article 9(3) of Regulation (EC) No 1107/2009, the rapporteur Member State notified the applicants, the
other Member States, the Commission and the European Food Safety Authority (‘the Authority’) of the admissibility
of the application on 7 July 2015.
(3) For that active substance, the effects on human and animal health and the environment have been assessed, pursuant
to Article 11(2) and (3) of Regulation (EC) No 1107/2009, for the use proposed by the applicants. The rapporteur
Member State submitted a draft assessment report to the Commission and to the Authority on 17 March 2017.
(4) Pursuant to Article 12(1) of Regulation (EC) No 1107/2009, the Authority circulated the draft assessment report
received from the rapporteur Member State to the applicant and the other Member States and organised a public
consultation on it.
(5) Pursuant to Article 12(3) of Regulation (EC) No 1107/2009, the Authority requested that the applicants supply
additional information to the Member States, the Commission and the Authority.
(6) The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the
form of an updated draft assessment report.
(7) The draft assessment report was reviewed by the Member States and the Authority. The Authority presented to the
Commission its conclusion(2) on the risk assessment of the active substance 1,3-dichloropropene on 8 October
2018.
(8) In its conclusion, the Authority indicated that based on the available information presented in the dossier it could
not finalise the risk assessment for consumers, operators, workers, bystanders and residents and identified potential
concerns for groundwater, non-target arthropods (including bees), birds and mammals, and soil organisms for all
representative uses.
(1) OJ L 309, 24.11.2009, p. 1.
(2) EFSA Journal 2018;16(11):5464, Conclusion on the peer review of the pesticide risk assessment of the active substance
(EZ)-1,3-Dichloropropene. doi:10.2903/j.efsa.2018.5464.16.5.2022 EN Official Journal of the European Union L 137/11
(9) The Commission invited the applicants to submit their comments on the conclusion of the Authority and, in
accordance with Article 13(1) of Regulation (EC) No 1107/2009, on the draft review report. The applicants
submitted their comments, which have been carefully examined.
(10) The Commission presented its review report and a draft of this Regulation regarding the non-approval of the active
substance 1,3-dichloropropene to the Standing Committee on Plants, Animals, Food and Feed on 22 October 2021.
The Commission observed that concerns identified by the Authority could not be eliminated and that consequently
it could not be concluded that the approval criteria are satisfied.
(11) By letter of 19 January 2022, the applicants withdrew their application for the approval of 1,3-dichloropropene.
Therefore, 1,3-dichloropropene should not be approved.
(12) This Regulation does not prevent the submission of a further application for the approval of 1,3-dichloropropene
pursuant to Article 7 of Regulation (EC) No 1107/2009.
(13) 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
Non-approval of the active substance
The active substance 1,3-dichloropropene is not approved.
Article 2
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, 13 May 2022.
For the Commission
The President
Ursula VON DER LEYEN