EUROPE – COM: Public Consultation on the Amendment of Data Requirements and Uniform Principles for active substances and PPPs

The European Commission has launched a public consultation for the amendment of the regulations setting out the data requirements for active substance (AS) (i.e. regulation (EU) 283/2013) and plant protection products (PPP) (i.e. regulation (EU) 284/2013), and the uniform principles for the evaluation of PPP (i.e. regulation (EU) 546/2011). The objective is to reflect evolutions in methodologies for conducting regulatory studies and risk assessments, and in particular:

The data requirements for the toxicology and ecotoxicology sections have been modified to (i) include details related to the methodology of EFSA to assess endocrine disruptor properties (EFSA Journal 2018;16(6):5311) and (ii) reinforce the objective to avoid and reduce standard testings with vertebrate animals (e.g. a fish embryo acute toxicity test has been provided for as an alternative to the standard fish acute toxicity test).

Additionally, the possibility to use a benchmark dose (BMD) approach, in connection with the recent EFSA guidance on the use of this approach in risk assessment (EFSA Journal 2022;20(10):7584), and a specific section on developmental neurotoxicity have been introduced in the toxicology section.

Amendments on data requirements and uniform principles have been performed to reflect the new protection goal agreed for honeybee colonies and the recently revised EFSA guidance on bees (EFSA Journal 2023;21(5):7989). Data requirements for bumblebees and solitary bees have now been explicitly provided for in addition to those for honeybees.

Additionally, new paragraphs related to the recent EFSA guidance on the impact of water treatment processes on residues in drinking water (EFSA Journal 2023;21(8):8194) have been included.

Besides, amended paragraphs are also proposed to clarify and provide examples when a (scientific) justification can be provided to waive part of the AS and/or PPP data requirements or when Applicants can propose alternative approaches. It concerns AS that, due to their nature, are unlikely to cause harm to humans and animals or unacceptable effects on the environment, in particular if the AS are of biological origin or are functionally identical and structurally similar to one of biological origin.

Comment(s) on the draft regulations shall be submitted until 02 October 2025 via the public consultation webpages (see the “To download” section below).

To download: 

Draft regulation and its annex to amend Regulation (EU) No. 283/2013 (Ares(2025)7239411 and Ares(2025)7239411) (data requirement for active substances)

Draft regulation and its annex to amend Regulation (EU) No. 284/2013 (Ares(2025)7239395 and Ares(2025)7239395) (data requirement for plant protection products)

Draft regulation and its annex to amend Regulation (EU) No. 546/2011 (Ares(2025)7239378 and Ares(2025)7239378) ( uniform principles for the evaluation of plant protection products)

See also our previous articles: 

EUROPE – COM: Availability and applicability of the EFSA/ECHA guidance on identifying endocrine disruptors

EUROPE – EFSA: Revised Bee Guidance Released

EUROPE: Adoption of the EFSA/ECHA Guidance on the Impact of Water Treatment Processes on Residues in Drinking Water

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/

Photo credit: Alexas_Fotos/pixabay