As a general principle, different sources of technical material for the same active substance must present a comparable level of health and environmental hazard.
This webinar aims to present how to prepare a technical equivalence dossier, and how it is assessed by the competent authorities in Europe.
This webinar provides a structured overview of the key principles of CLP classification as applied to PPPs. It will cover the core elements of a CLP classification, the use of ECHA Chem, the different approaches to classifying substances and mixtures (including calculation-based methods), as well as practical examples to illustrate and apply the concepts discussed.
Biocidal Product Renewals: What You Need to Anticipate Now
Renewing a biocidal product authorisation is becoming increasingly complex: evolving guidance, changing regulatory expectations, divergent national situations, data protection expiry, and tricky case by case scenarios.
In this webinar, we’ll break down the key renewal pathways, highlight the pitfalls to avoid, and show you how early anticipation can protect your portfolio and streamline your next RNL submission.
Biocidal Product Authorisation Renewals: Anticipating to keep Control
Renewing a biocidal product authorisation is a strategic step that raises many questions: dossier harmonisation, regulatory updates, technical changes, active substances under review, or the impact of new EU guidance. The coming years will bring significant updates (regulations, evaluation models, IUCLID requirements, etc.) and complex situations that can strongly influence renewal strategies.
This webinar aims to provide a clear overview of the main renewal scenarios, identify key risks, and explain how to anticipate effectively to avoid end of cycle complications. Without entering confidential or overly technical territory, we will highlight observed trends, potential impacts on product portfolios, and best practices for building a robust renewal (RNL) strategy.
Before the publication of Regulation 2024/1487, the regulatory requirements for safeners and synergists varied from country to country. This webinar aims to present the key changes introduced by the new Regulation. We will review the positive list and the associated work programme, outline the data requirements and approval process for obtaining authorization for safeners and synergists, and conclude with a discussion of the actions to be taken if your plant protection product formulation contains one of these substances.
This webinar provides an overview of adjuvant legislation, with a focus on national requirements and applicable technical obligations. It will also highlight the regulatory and technical specificities of adjuvants particularly in France and Belgium, in comparison with plant protection products, to clarify key challenges and points of attention for their placement on the market.
The topic of adjuvant efficacy will not be covered in this webinar, as a webinar dedicated to this topic is already available.
In March 2021, the Transparency Regulation revising the General Food Law entered into force, fundamentally transforming the preparation, submission, and evaluation of active substance approval dossiers. New concepts such as study notification, IUCLID submissions, and information sanitization were introduced, and applicants worked to comply with these updated requirements. Five years after its implementation, this webinar will review the major changes brought by the Regulation and how these changes have been applied in practice. It will also highlight the positive outcomes and the challenges encountered, particularly in terms of efficiency, costs, and transparency.
This webinar provides a clear and practical overview of in vitro skin penetration studies conducted in accordance with OECD Guideline 428 and EFSA 2017 guidance. It covers radiolabeled and non‑radiolabeled approaches, the analysis of skin compartments, and specific considerations for volatile, photosensitive, or hydrolysis‑sensitive substances in a regulatory context.
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