Amendment of data requirements for applications for the approval of active substances

Referring to Section 8.2.1. Acute toxicity to fish: Current text: "A study shall be provided on the acute toxicity to rainbow trout (Oncorhynchus mykiss) (LC50) and details of observed effects. Alternatively, a suitable non-vertebrate test (e.g. fish embryo acute toxicity test) may be carried out." It would be useful to more clearly lay out the use of alternative methods: 1.

POLLINIS welcomes the European Commissions initiative to revise Regulation (EU) No 283/2013 and appreciates the opportunity to share its perspective on the proposed updates. We value the Commissions recognition of the need to base pesticide risk assessments on the most current scientific evidence and to apply testing methods that are both precise and sensitive.

Ascenza Agro SA appreciates the opportunity to provide feedback on the draft Commission Regulation amending Commission Regulation (EU) 283/2013. We consider this is a good opportunity to align criteria regarding trigger values for conducting field rotational studies between European Regulation and EFSA and OECD guidelines.

Pesticide Action Network Europe (PAN Europe) welcomes the initiative of the European Commission to update the data requirements laid down in Regulation (EU) No 283/2013 and appreciates the opportunity to provide comments on the draft Commission Regulation amending this legal framework.

AEFA (Spanish Association of Agronutrient Manufacturers) appreciates the opportunity provided by the European Commission to contribute to the public consultation on the new Draft Data Requirements for applications to approve active substances. Please find attached general feedback

Filed in Spanish · English published by the European Commission

In the introduction ANNEX, for the sake of consistency of biocontrol definition, there is the need of including "minerals" as category. In the Introduction there is the need of adding: A dossier shall be submitted in accordance with Part A if the active substance is: (c) mineral In addition, for consistency with the Commission Delegated Regulation (EU) 2023/707, we suggest updating point (w) at page 9 adding "this…

In the introduction ANNEX, for the sake of consistency of biocontrol definition, there is the need of including "minerals" as category. In the Introduction there is the need of adding: A dossier shall be submitted in accordance with Part A if the active substance is: (c) mineral In addition, for consistency with the Commission Delegated Regulation (EU) 2023/707, we suggest updating point (w) at page 9 adding "this…

In the introduction ANNEX, for the sake of consistency of biocontrol definition, there is the need of including "minerals" as category. In the Introduction there is the need of adding: A dossier shall be submitted in accordance with Part A if the active substance is: (c) mineral In addition, for consistency with the Commission Delegated Regulation (EU) 2023/707, we suggest updating point (w) at page 9 adding "this…

Thank you for the opportunity to comment. The amendments of Commission Regulation (EU) No 283/2013 and Commission Regulation (EU) No 284/2013 would have been the perfect opportunity to define specific requirements for low risk active substances and products containing low risk substances. Unfortunately, this opportunity was not taken advantage of.

In the introduction ANNEX, for the sake of consistency of biocontrol definition, there is the need of including "minerals" as category. In the Introduction there is the need of adding: A dossier shall be submitted in accordance with Part A if the active substance is: (c) mineral In addition, for consistency with the Commission Delegated Regulation (EU) 2023/707, we suggest updating point (w) at page 9 adding "this…

CropLife Europe (CLE) welcomes the opportunity to comment on the proposed revision of the data requirements for active substances used in plant protection products. CLE supports the Commissions aim of strengthening scientific quality and coherence with other EU legislation but considers that several provisions would benefit from clarification to ensure feasibility, proportionality, and global alignment.

1. In the introduction ANNEX, for the sake of consistency of biocontrol definition, there is the need of including "minerals" as category. In the Introduction there is the need of adding: A dossier shall be submitted in accordance with Part A if the active substance is: (c) minerals 2. In addition, minerals like copper e.g.

In the introduction ANNEX, for the sake of consistency of biocontrol definition, there is the need of including "minerals" as category. In the Introduction there is the need of adding: A dossier shall be submitted in accordance with Part A if the active substance is: ..... (c) mineral Which are to be considered among Natural substances.

It is now widely recognized that biodiversity is being severely undermined by the massive use of pesticides, industrialization, soil artificialization, and global warming. The ever-increasing use of pesticides worldwide is particularly being called into question because products are authorized for market release based on tests that are inadequate or even flawed.

It is now recognised that biodiversity is being undermined in competition by the massive use of pesticides, industrialisation, soil lartificialisation and global warming. The use of pesticides, which is still growing worldwide, is particularly marked by the fact that products assessed with insufficient or defective tests have been authorised on the market.

Filed in French · English published by the European Commission

Page 39: A DNT in vitro battery (DNT-IVB) on the active substance, assessed based on OECD recommendations is negative Comment: The term negative requires clarification. negative means that all 17 specific endpoints of the battery have to be negative; unless there is evidence of an ED mode of action. If one test shows a hit above the specific Benchmark Response (BMR), the active substance is considered a positive.

IBMA would like to thank the European Commission for the opportunity to provide comments on the new Draft Data Requirements for applications to approve active substances. Please find attached our general feedback together with the detailed commenting tables.

Humane World for Animals appreciates the opportunity to provide feedback on the draft text of the Act on Active Substances. We acknowledge the efforts made to integrate scientific advances and updated procedures, such as the newly added Article 10 under Section 5 for active substances, that represent important steps toward reducing reliance on animal testing.

Thank you for providing the opportunity to give feedback regarding an update of the data requirements for active substances in plant protection products. We appreciate new provisions regarding clarification that companies must submit all studies, and a new requirement for developmental neurotoxicity (DNT) testing. We provide specific suggestions to further strengthen these points.

Comment related to: 284/2012 - 1.5: We would like to point out that sufficient scientific knowledge and expertise need to be present at authorities in order to understand and evaluate scientific statements in cases where, due to the complex nature of an active substance of biological origin (e.g. plant extracts) certain studies are not possible to be performed.

PETA Science Consortium International e.V. (the Science Consortium) is grateful for the opportunity to comment on the draft amending Commission Regulation (EU) No 283/2013 as regards the information to be submitted for active substances.

Comments regarding Regulation (EU) No 283/2013 have been provided as an annex, prepared by E-V-A on behalf of the Ministry of Agriculture and Rural Development. For clarity, these comments pertain to the information to be submitted for active substances, as set forth in Commission Regulation (EU) No 283/2013 implementing Regulation (EC) No 1107/2009.