Date: 2025-05-08Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2025/881 of 7 May 2025 amending Implementing Regulations (EU) 2019/1085 and (EU) No 540/2011 as regards the conditions of approval of the active substance 1-methylcyclopropene
Issued by European Commission
· Directorate-General for Health and Food Safety
Here's an informative report based on the provided policy text, following the specified structure and focusing on its nature as an **Amendment**.
**Report: Analysis of Commission Implementing Regulation (EU) 2025/881 Amending Regulations (EU) 2019/1085 and (EU) No 540/2011 regarding 1-methylcyclopropene**
**1. Executive Summary:**
This report analyzes Commission Implementing Regulation (EU) 2025/881, an amendment to existing regulations (EU) 2019/1085 and (EU) No 540/2011 concerning the active substance 1-methylcyclopropene. The core purpose of this amendment is to broaden the approved uses of 1-methylcyclopropene as a plant growth regulator by removing the restriction to post-harvest storage in sealable warehouses and allowing pre-harvest, in-field applications. Key findings include the introduction of new application methods, a requirement for confirmatory information from the applicant regarding environmental and health impacts, and specific considerations for Member States regarding groundwater protection.
**2. Introduction:**
This report aims to provide a comprehensive overview and analysis of Commission Implementing Regulation (EU) 2025/881 based solely on the provided text. The focus is on understanding the nature of the amendments, the reasoning behind them, and their potential implications for stakeholders.
**3. Policy Overview:**
* This regulation amends Implementing Regulations (EU) 2019/1085 and (EU) No 540/2011, which pertain to the approval and conditions of use for the active substance 1-methylcyclopropene.
* **Core Objective(s):** The primary objective of this amendment is to expand the permitted uses of 1-methylcyclopropene to include pre-harvest applications in fields via orchard spray fed by direct injection systems, beyond its currently approved use in post-harvest storage. A secondary objective is to gather further data on the environmental and health impacts of 1-methylcyclopropene.
**4. Background and Rationale:**
The amendment is likely driven by an application from AgroFresh Holding France SAS seeking to expand the permitted uses of 1-methylcyclopropene. The original regulations restricted its use to post-harvest storage in sealable warehouses. The applicant provided data supporting the safety and efficacy of pre-harvest applications. This amendment aims to address perceived limitations in the scope of the original approval and allow for a broader range of applications for this active substance.
**5. Key Provisions / Changes:**
This section details the specific changes introduced by the amendment:
* **Specific Part of Original Policy Changed:** The amendment modifies the conditions of approval for 1-methylcyclopropene as set out in Part B of the Annex to Commission Implementing Regulation (EU) No 540/2011 and Annex I to Implementing Regulation (EU) 2019/1085.
* **New Rule/Provision:** The restriction limiting the use of 1-methylcyclopropene to post-harvest storage in sealable warehouses is removed, allowing for pre-harvest applications in fields via orchard spray fed by direct injection systems. The amended Annexes include a specific provision requiring the applicant to submit confirmatory information regarding the presence and potential risks of methallyl alcohol in soil and aquatic compartments and regarding the effect of water treatment processes on the nature of residues present in drinking water.
* **Difference/Effect of Change:** This change expands the market for 1-methylcyclopropene by allowing its use in pre-harvest applications. The confirmatory information requirement aims to provide greater certainty about the environmental and health safety of the expanded use. The specific provisions added to the Annexes to Implementing Regulation (EU) No 540/2011 and Implementing Regulation (EU) 2019/1085 also direct Member States to pay particular attention to the protection of groundwater when the substance is applied in regions with vulnerable soil and climatic conditions.
**6. Target Audience and Stakeholders:**
* AgroFresh Holding France SAS (the applicant) is directly affected, as the amendment allows them to market 1-methylcyclopropene for a broader range of uses.
* Farmers and agricultural businesses that could potentially use 1-methylcyclopropene for pre-harvest applications are directly affected.
* Member States' regulatory bodies responsible for implementing plant protection product regulations are directly affected.
* The European Food Safety Authority (EFSA) is involved in the review of confirmatory data.
* Consumers and environmental groups are stakeholders due to the potential environmental and health impacts of the expanded use.
**7. Implementation Aspects (Inferred):**
* **Responsible Agency/Bodies:** The Commission, Member States, and the European Food Safety Authority (EFSA) are involved in the implementation of this amendment. Member States are responsible for considering groundwater protection in their overall assessment.
* **Timelines/Procedures:** The applicant (AgroFresh Holding France SAS) must submit the confirmatory information by 27 May 2027 (two years from the regulation's entry into force). The regulation enters into force on the twentieth day following its publication in the Official Journal of the European Union.
**8. Expected Outcomes / Impact of Changes:**
* The intended outcome of these changes is to provide growers with an additional tool for plant growth regulation that can be applied pre-harvest.
* The amendment aims to promote innovation in plant protection products while ensuring a high level of protection for human health and the environment.
* The collection and assessment of confirmatory data on methallyl alcohol and water treatment effects are intended to mitigate potential risks associated with the expanded use of 1-methylcyclopropene.
**9. Conclusion:**
Commission Implementing Regulation (EU) 2025/881 represents a significant amendment to existing regulations governing the use of 1-methylcyclopropene. By expanding the approved applications to include pre-harvest uses, the regulation has the potential to impact agricultural practices and the plant protection product market. The requirement for confirmatory data underscores the importance of ongoing monitoring and assessment to ensure environmental and health safety. The amended regulation ensures a more comprehensive and updated regulatory framework, reflecting the evolving needs and scientific understanding related to the use of 1-methylcyclopropene.
Key Entities Referenced
Official Journal EN of the European Union L series 2025/881: Publication in which the regulation is published.
COMMISSION IMPLEMENTING REGULATION (EU) 2025/881: The regulation being analyzed.
7 May 2025: Date of the COMMISSION IMPLEMENTING REGULATION (EU) 2025/881
Implementing Regulations (EU) 2019/1085: Regulation being amended by this regulation.
Implementing Regulation (EU) No 540/2011: Regulation being amended by this regulation.
1-methylcyclopropene: Active substance whose conditions of approval are being amended.
EEA: European Economic Area
Treaty on the Functioning of the European Union: Legal basis for the regulation.
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: One of the legislative bodies of the European Union.
Council: Refers to the Council of the European Union.
21 October 2009: Date of Regulation (EC) No 1107/2009
Council Directives 79/117/EEC: Repealed Council Directive related to plant protection products.
91/414/EEC: Repealed Council Directive related to plant protection products.
Article 13(2c): Article within Regulation (EC) No 1107/2009 that provides the legal basis for this regulation.
Commission Implementing Regulation (EU) 2019/1085: Regulation that renewed the approval of 1-methylcyclopropene.
Part B of the Annex to Commission Implementing Regulation (EU) No 540/2011: Section specifying the conditions of approval of 1-methylcyclopropene.
Article 71 of Regulation (EC) No 1107/2009: Article governing application for amendment of approval conditions.
4 March 2019: Date when AgroFresh Holding France SAS submitted the application.
AgroFresh Holding France SAS: Applicant seeking amendment to the conditions of approval of 1-methylcyclopropene.
Netherlands: Designated rapporteur Member State.
Article 4 of Regulation (EC) No 1107/2009: Article related to the potential effects on human and animal health and the environment.
European Food Safety Authority: The Authority that reviews the renewal assessment report.
Authority: Refers to the European Food Safety Authority.
12 October 2021: Date when the revised renewal assessment report was submitted to the EFSA and the Commission.
Article 12(1) of Regulation (EC) No 1107/2009: Article governing the circulation of the revised renewal assessment report.
Article 12(3) of Regulation (EC) No 1107/2009: Article governing request for additional information from the applicant.
October 2023: Date when the rapporteur Member State submitted the revised renewal assessment report to the Commission and the Authority.
19 July 2024: Date when the Authority communicated to the Commission its conclusion.
Standing Committee on Plants, Animals, Food and Feed: Committee that received the addendum to the renewal report and the draft of the regulation.
4 December 2024: Date of the addendum to the renewal report for 1-methylcyclopropene.
12 March 2025: Date of the draft of this Regulation
Article 29(6) of Regulation (EC) No 1107/2009: Article related to uniform principles for implementation.
Brussels: Location where the regulation was adopted.
Ursula VON DER LEYEN: The President of the Commission
27 May 2027: Date by which confirmatory information shall be submitted
Official Journal EN
of the European Union L series
2025/881 8.5.2025
COMMISSION IMPLEMENTING REGULATION(EU) 2025/881
of 7 May 2025
amending Implementing Regulations (EU) 2019/1085 and (EU) No 540/2011 as regards the
conditions of approval of the active substance 1-methylcyclopropene
(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)(c) thereof,
Whereas:
(1) Commission Implementing Regulation (EU) 2019/1085(2) renewed the approval of the active substance
1-methylcyclopropene.
(2) Following that renewal, the approval of the active substance 1-methylcyclopropene, as set out in Part B of the Annex
to Commission Implementing Regulation (EU) No 540/2011(3), includes a restriction to uses as plant growth
regulator in post-harvest storage in sealable warehouses only.
(3) In accordance with Article 7(1) of Regulation (EC) No 1107/2009, on 4 March 2019, AgroFresh Holding France SAS
submitted an application to the designated rapporteur Member State, the Netherlands, seeking an amendment to the
conditions of approval of 1-methylcyclopropene in order to remove the restriction to uses as plant growth regulator
in post-harvest storage in sealable warehouses only and to allow pre-harvest in field uses via orchard spray fed by
direct injection system. The application was found to be admissible by the rapporteur Member State.
(4) The rapporteur Member State assessed the proposed new uses of the active substance 1-methylcyclopropene in
relation to the potential effects on human and animal health and the environment in accordance with Article 4 of
Regulation (EC) No 1107/2009 and prepared a revised renewal assessment report which was submitted to the
European Food Safety Authority (‘the Authority’) and the Commission on 12 October 2021.
(5) In accordance with Article 12(1) of Regulation (EC) No 1107/2009, the Authority circulated the revised renewal
assessment report to the applicant and to the Member States for comments and made it available to the public. In
accordance with Article 12(3) of Regulation (EC) No 1107/2009, additional information was requested from the
applicant. The rapporteur Member State evaluated the additional information and submitted the revised renewal
assessment report to the Commission and to the Authority in October 2023.
(1) OJ L 309, 24.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1107/oj.
(2) Commission Implementing Regulation (EU) 2019/1085 of 25 June 2019 renewing the approval of the active substance
1-methylcyclopropene, 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, and amending the Annex to Commission Implementing Regulation (EU)
No 540/2011, and amending the Annex to Commission Implementing Regulation (EU) 2015/408. (OJ L 171, 26.6.2019, p. 110,
ELI: http://data.europa.eu/eli/reg_impl/2019/1085/oj).
(3) Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the
European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1, ELI: http://data.
europa.eu/eli/reg_impl/2011/540/oj).
ELI: http://data.europa.eu/eli/reg_impl/2025/881/oj 1/4EN
OJ L, 8.5.2025
(6) On 19 July 2024, the Authority communicated to the Commission its conclusion(4)on whether the proposed new
uses of the active substance 1-methylcyclopropene can be expected to meet the approval criteria provided for in
Article 4 of Regulation (EC) No 1107/2009.
(7) The Commission presented to the Standing Committee on Plants, Animals, Food and Feed an addendum to the
renewal report for 1-methylcyclopropene on 4 December 2024 and a draft of this Regulation on 12 March 2025,
respectively.
(8) The Commission invited the applicant to submit comments on the addendum to the renewal report. The applicant
submitted comments, which have been carefully examined.
(9) It has been established with respect to one or more representative uses of at least one plant protection product
containing the active substance 1-methylcyclopropene that the approval criteria provided for in Article 4 of
Regulation (EC) No 1107/2009 are satisfied for the new uses. It is therefore appropriate to remove the restriction
and to allow pre-harvest in field uses.
(10) In addition, to increase the confidence in the decision, the applicant should submit to the Commission, the Member
States and the Authority confirmatory information as regards the presence of methallyl alcohol in soil and aquatic
compartments and, if it is formed in relevant amounts, information on its toxicological properties and potential risk
to aquatic and soil organisms. Moreover, the applicant should submit information as regards the effect of water
treatment processes on the nature of residues present in drinking water. That confirmatory information should be
submitted within 2 years from the date of entry into force of this Regulation.
(11) Implementing Regulations (EU) 2019/1085 and (EU) No 540/2011 should therefore be amended accordingly.
(12) 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
Amendment to Implementing Regulation (EU) 2019/1085
Annex I to Implementing Regulation (EU) 2019/1085 is amended in accordance with the Annex to this Regulation.
Article 2
Amendment to Implementing Regulation (EU) No 540/2011
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.
(4) EFSA (European Food Safety Authority), Anastassiadou M, Arena M, Auteri D, Brancato A, Bura L, Carrasco Cabrera L, Chaideftou E,
Chiusolo A, Crivellente F, De Lentdecker C, Egsmose M, Fait G, Greco L, Ippolito A, Istace F, Jarrah S, Kardassi D, Leuschner R, Lostia
A, Lythgo C, Magrans O, Mangas I, Miron I, Molnar T, Padovani L, Parra Morte JM, Pedersen R, Reich H, Santos M, Sharp R, Stanek A,
Sturma J, Szentes C, Terron A, Tiramani M, Vagenende B and Villamar-Bouza L, 2024. Conclusion on the peer review of the pesticide
risk assessment of the active substance 1-methylcyclopropene. EFSA Journal. 2024;22:e8977. https://doi.org/10.2903/
j.efsa.2024.8977.
2/4 ELI: http://data.europa.eu/eli/reg_impl/2025/881/ojEN
OJ L, 8.5.2025
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, 7 May 2025.
For the Commission
The President
Ursula VON DER LEYEN
ELI: http://data.europa.eu/eli/reg_impl/2025/881/oj 3/4EN
OJ L, 8.5.2025
ANNEX
The column ‘Specific provisions’ of Annex I to Implementing Regulation (EU) 2019/1085 is replaced by the following:
‘For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the
conclusions of the review report on 1-methylcyclopropene, and in particular Appendices I and II thereto, shall be taken
into account.
In this overall assessment Member States shall pay particular attention to:
— the protection of groundwater, when the substance is applied in regions with vulnerable soil and climatic conditions.
Conditions of use shall include risk mitigation measures, where appropriate.
The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards
the presence of methallyl alcohol in soil and aquatic compartments and, if formed in relevant amounts, information on its
toxicological properties and potential risk to aquatic and soil organisms and as regards the effect of water treatment
processes on the nature of residues present in drinking water. The confirmatory information shall be submitted by 27 May
2027.’
The column ‘Specific provisions’ of row 136, 1-methylcyclopropene, in Part B of the Annex to Implementing Regulation
(EU) No 540/2011 is replaced by the following:
‘For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the
conclusions of the review report on 1-methylcyclopropene, and in particular Appendices I and II thereto, shall be taken
into account.
In this overall assessment Member States shall pay particular attention to:
— the protection of groundwater, when the substance is applied in regions with vulnerable soil and climatic conditions.
Conditions of use shall include risk mitigation measures, where appropriate.
The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards
the presence of methallyl alcohol in soil and aquatic compartments and, if formed in relevant amounts, information on its
toxicological properties and potential risk to aquatic and soil organisms and as regards the effect of water treatment
processes on the nature of residues present in drinking water. The confirmatory information shall be submitted by 27 May
2027.’
4/4 ELI: http://data.europa.eu/eli/reg_impl/2025/881/oj